Technical Investigator Stellenangebote

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Stellenangebote Technical Investigator Jobs

Job am 20.03.2025 bei StepStone gefunden Elanco Animal Health GmbH

Clinical Study Manager (m/w/d)

• Monheim Homeoffice möglich Jobticket Job Description Clinical Study Manager Veterinarian-Animal Center Monheim (m/f/d) The position is an excellent career opportunity for candidates with a strong veterinary background who aspire[...]

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[...] conduction in compliance with Animal Welfare requirements and local regulations. YOUR TASKS AND RESPONSIBILITIES Veterinary health management of the animals on stock within the Animal Center Monheim in accordance with official and Animal Welfare requirements Serve as responsible Study Manager/ Investigator on internal and external research and development studies (GRP, GCP, GLP standard) Organization and coordination of study activities together with other involved technical functions (e. g. laboratory technicians) Establishment of study protocols and reports Support of internal customers (e. g. project teams in [...]
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Job vor 2 Tagen bei Jobleads gefunden Sr Regulatory Medical Writer Description Sr Medical Writer Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs[...]

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[...] are passionate to change lives. Discover what our 29, 000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture-where you can [...] or supports a variety of documents that include but not limited to: Clinical study protocols and clinical protocol amendments; Clinical study reports; Patient narratives; Clinical development plans; IND submissions and annual reports; Integrated summary reports; NDA and (e) CTD submissions; Investigator brochures, as well as; Clinical journal manuscripts, clinical journal abstracts, and client presentations. Reviews statistical analysis plans and table/ figure/ [...]

Job vor 3 Tagen bei Jobleads gefunden

Senior Medical Science Liaison-Germany (North)

We give it our all every day because we believe in the power of targeted oncology to change the outlook for people with cancer. The[...]

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[...] and facilitate the appropriate exchange of scientific information. Communicate experts opinion and feedback on new data and clinical trends to Medical Affairs and translate this information into strategic recommendations. Act as primary liaison to investigators interested in developing and performing investigator-initiated research. Collaborate with the Clinical Operations organization to enhance patient enrollment in company-sponsored clinical trials. Serve as medical lead and [...] Rare disease experience preferred, particularly in Oncology and/or Neurosciences. Demonstrated mastery of effectively presenting clinical/ scientific information. Expert level proficiency with business software including Veeva CRM or a comparable customer relations management tool. Ability to understand, review, and communicate complex technical concepts and technologies. Working knowledge of the relevant national compliance guidance for pharmaceutical manufacturers. Leadership skills including experience working with [...]

Job vor 7 Tagen bei Jobleads gefunden Associate Specialist, Clinical Trials • Allschwil, Basel- Landschaft Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We[...]

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[...] Manages essential document collection and Institutional Review Board (IRB) and Ethics Committee (IEC) submission and approval procedures from start up through closeout for assigned trials. Collaborates with clinical research colleagues within Neurocrine, at Contract Research Organizations (CROs) , and at Investigator sites to conduct clinical trials adhering to Good Clinical Practice (GCP) and ensuring accurate data, subject safety and impeccable documentation. [...] with Food and Drug Administration (FDA) regulations, EU Directive, International Conference on Harmonization (ICH) guidelines, and NBI Standard Operating Procedures (SOPs) and policies Serves as a team member of assigned clinical studies Assist in the preparation of data/ information for technical and study design discussions Provides administrative support, ensuring invoices are paid, tracking metrics, issues for CROs and other contract service [...]
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Job vor 8 Tagen bei Jobleads gefunden

Principal Regulatory Medical Writer

Description Principal Medical Writer Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs[...]

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[...] their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture-where you can [...] or supports a variety of documents that include but not limited to: Clinical study protocols and clinical protocol amendments; Clinical study reports; Patient narratives; Clinical development plans; IND submissions and annual reports; Integrated summary reports; NDA and (e) CTD submissions; Investigator brochures, as well as; Clinical journal manuscripts, clinical journal abstracts, and client presentations. Reviews statistical analysis plans and table/ figure/ [...]

Job am 24.03.2025 bei Jobleads gefunden Leiter Kundenbetreuung (d/w/m) • Essen, Nordrhein- Westfalen Führungs-/ Leitungspositionen Remote/ Hybrid/Office based working options. Our Sponsor Dedicated (cFSP) team are growing, join us on our mission to drive healthcare forward As Clinical Research Associate,[...]

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[...] Associate, you will be developing the local contracting strategy and support the delivery of all required start-up contracting activities for selected sponsors, studies, or multi-protocol programs as determined by the Sponsors requirements. Job Overview: Develop and coordinate the development of investigator grants and estimates, contracting strategies, and proposal text to support the proposal development process. Develop contract language, payment language, and [...] or clinical research organization clinical site contracting experience, including demonstrable global and/or regional experience acting as a contract negotiator. Equivalent combination of education, training, and experience. Good negotiating and communication skills with the ability to challenge. Strong legal, financial, and/or technical writing skills. Good understanding of clinical trial contract management. Ability to utilise metrics and communicate these with the study team [...]
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Job am 18.03.2025 bei Jobleads gefunden

Site Contracts Specialist 2 or Sr. Must be fluent in English and Turkish. Essential to have sol. . .

• Köln, Düsseldorf, Dortmund, Nordrhein- Westfalen Site Contracts Specialist 2 or Sr. Must be fluent in English and Turkish. Essential to have solid working experience with Turkish Site Contracts Updated: March[...]

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[...] are passionate to change lives. Discover what our 29, 000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture where you [...] lead multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials. Produces site-specific contracts from country clinical trial agreement (CTA) template. Reviews and owns site-specific contracts from country template. Submits proposed CTA and investigator budget for site review. Negotiates budget and contract with site and via Site Contracts Service Centre and SSUL with Sponsor [...]
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Job am 09.03.2025 bei Jobleads gefunden Medical Science Liaison Oncology (central Germany) Homeoffice möglich Medical Science Liaison Oncology (central Germany) Join to apply for the Medical Science Liaison Oncology (central Germany) role at Menarini Stemline. Reports to Medical Lead[...]

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[...] of Stemlines pipeline, disease state awareness and general scientific discussions of data with Key Opinion Leaders (KOLs) and Health Care Providers (HCPs) . The MSL will represent Stemline in the support of research interest with both Company Sponsored Trials and Investigator Initiated Research. MSLs provide medical information through scientific exchange in a fair and balanced manner and provide clinical/ scientific support. [...] to organize, prioritize, and work effectively in a constantly changing environment. Strong compliance knowledge and adherence to corporate compliance policies. Current working knowledge of ICH, GCP and other compliance regulations and guidelines relevant to industry interactions with healthcare professionals. Demonstrated technical acumen including MS Office skills, ability to adopt and leverage multiple business applications. This position will require greater than 75 [...]

Job am 09.03.2025 bei Jobleads gefunden

Senior Clinical Research Associate

• München, Bayern Senior Clinical Research Associate page is loaded Senior Clinical Research Associate Apply remote type Remote locations Munich-Remote time type Part time posted on Posted 3[...]

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[...] other site-related issues. KEY RESPONSABILITIES Provides guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements. Reviews monitoring visit reports, conducts co-monitoring and evaluation visits as needed. Ensures appropriate and timely investigator site visits. Coordinates with appropriate cross-functional departments to facilitate negotiation/ issue resolution for clinical trial monitoring related issues. Assists in [...] experience in the pharmaceutical/ biotechnology/ CRO industry, 2 years of clinical monitoring experience with 1 year of management experience EU: Minimum 2 years of clinical monitoring experience in the pharmaceutical/ biotechnology/ CRO industry and ability to autonomously manage monitoring activities TECHNICAL COMPETENCES SOFT SKILLS Quality focused; Proven ability to be careful, thorough, and detail-oriented Strong organizational skills and the ability to [...]

Job am 08.03.2025 bei Jobleads gefunden Principal/ Sr Regulatory Medical Writer (Portugal/ Spain/ France/ Belgium/Germany/ Hungary) • Köln, Düsseldorf, Dortmund, Nordrhein- Westfalen Principal/ Sr Regulatory Medical Writer (Portugal/ Spain/ France/ Belgium/Germany/ Hungary) Updated: March 3, 2025 Location: Germany-Europe-DEU-Home-Based Job ID: 25001934 Syneos Health is a leading fully[...]

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[...] are passionate to change lives. Discover what our 29, 000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture where you [...] or supports a variety of documents that include, but not limited to: Clinical study protocols and clinical protocol amendments; Clinical study reports; Patient narratives; Clinical development plans; IND submissions and annual reports; Integrated summary reports; NDA and (e) CTD submissions; Investigator brochures, as well as; Clinical journal manuscripts, clinical journal abstracts, and client presentations. Identifies and proposes solutions to resolve issues [...]
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Job am 08.03.2025 bei Jobleads gefunden

MSL Oncology (Medical Science Liaison) - 6329

MSL Oncology (Medical Science Liaison) - 6329 Territory: French-speaking part of Switzerland, Bern, Solothurn, Ticino Our client is a global pharmaceutical company developing targeted and[...]

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[...] scientific events, advisory boards, and presentations of study results. Build and maintain expertise in his/ her therapeutic area by continuous education and participation in national and international congresses and company events. Collect, analyze, pass on, and follow clinical trial proposals (investigator-initiated trials) . Collaborate with cross-functional teams to support clinical development and regulatory submissions. Work closely with the Key Account Managers [...] and initiating projects, or conducting clinical studies. Ability to build and maintain peer-level relationships with TAEs and other key external stakeholders. Quick self-learner, ability and willingness to work both collaboratively and autonomously. Strong communication and presentation skills, including communicating complex technical, scientific, or medical information to various audiences. Confident appearance, social competence, and diplomatic skills. Strong customer and patient orientation. Strategic [...]
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Job am 02.03.2025 bei Jobleads gefunden Principal/ Sr Regulatory Medical Writer (Portugal/ Spain/ France/ Belgium/Germany/ Hungary) Description Senior Medical Writer Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] are passionate to change lives. Discover what our 29, 000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture-where you can [...] or supports a variety of documents that include, but not limited to: Clinical study protocols and clinical protocol amendments; Clinical study reports; Patient narratives; Clinical development plans; IND submissions and annual reports; Integrated summary reports; NDA and (e) CTD submissions; Investigator brochures, as well as; Clinical journal manuscripts, clinical journal abstracts, and client presentations. Identifies and proposes solutions to resolve issues [...]

Job am 23.02.2025 bei Jobleads gefunden

Clinical Research Associate II (Germany)

• Köln, Nordrhein- Westfalen Clinical Research Associate II (Germany) Allucent Cologne, North Rhine-Westphalia, Germany At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world[...]

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[...] the trial protocol and in compliance with SOPs, applicable regulations, and the principles of Good Clinical Practice. In this role your key tasks will include: Governs quality standards for trial monitoring activities. Performs Selection, Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule. Adheres to project guidelines and Allucent SOPs for monitoring requirements. Monitors activities at clinical study [...] Opportunity for remote/ hybrid working depending on location. Leadership and mentoring opportunities. Participation in our Buddy Program as a new or existing employee. Internal growth opportunities and career progression. Financially rewarding internal employee referral program. Access to online soft-skills and technical training via Good Habitz and internal platforms. Eligibility for our Spot Bonus Award Program in recognition of going above and [...]

Job am 20.02.2025 bei Jobleads gefunden Contract Negotiator 2-FSP-German speaker • Wien Essential Functions Coordinate the development of investigator grants and estimates, contracting strategies and proposal text to support the proposal development process. Develop contract language, payment[...]

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Essential Functions Coordinate the development of investigator grants and estimates, contracting strategies and proposal text to support the proposal development process. Develop contract language, payment language and [...] the delivery of training materials. Qualifications Bachelors Degree in a related field OR 5 years of relevant sponsor or clinical research organization clinical site contracting experience. Good negotiating and communication skills with the ability to challenge. Strong legal, financial and/or technical writing skills. Strong understanding of the regulated clinical trial environment and knowledge of the drug development process. Good understanding of [...]

Job am 15.02.2025 bei Jobleads gefunden

Medical Advisor, Germany

• München, Bayern Position type: Office-based, in alignment with Blue Flex model Reporting Line: To Medical Director, Germany How will your role help us transform hope into reality?[...]

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[...] and promotional material for the corresponding indication Responsible for the medical review of all commercial, market access and medical materials Close collaboration with Information Officer (Informationsbeauftragte) Support interventional and non-Interventional clinical trials in close collaboration with R D teams Support Investigator initiated studies Collaborate with market access for HEOR, access required information Scientific communication Raises awareness of products/ areas through the [...] other German speaking countries/ DACH Region within the role to follow HCP preferences and close collaboration within the countries and the cross-border networks. What minimum qualifications do we require? PhD, MD, PharmD, Pharmacist, and other life sciences with proven medical/ technical background 3-5 years of experience in the biotech or pharmaceutical industry in a similar role. Experience in hematology/ oncology, rare [...]
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Job am 07.02.2025 bei Jobleads gefunden Biomarker Clinical Operations Lead in PDG • Basel, Basel- Stadt Führungs-/ Leitungspositionen Biomarker Clinical Operations Lead in PDG For our client, a leading pharmaceutical company in Basel, we are looking for a new team member as Biomarker[...]

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[...] functional stakeholders (e. g. study team members, biomarker science, CDx, procurement, testing site monitors, diagnostic partners, central lab) to execute biomarker/ IVD operational strategies, serving as a single point of contact for biomarker/ IVD operations on multiple study teams Provide technical knowledge of aspects related to biomarker analyses (e. g. sample collection and handling, assay, device and imaging technologies) Develop and oversee biomarker analysis TIMELINES, BUDGET, RISK, COMPLIANCE and QUALITY, ensuring adherence to ICH/ GCP, SOPs, ISO 20916 and regulatory requirements Attend operations team meetings and investigator/ monitor meetings, as applicable, to deliver presentations and in-depth trainings to internal and external stakeholders on biomarker and companion diagnostic [...]

Job am 04.02.2025 bei Jobleads gefunden Clinical Research Associate II (Germany) • München, Bayern Clinical Research Associate II (Germany) At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring[...]

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[...] the trial protocol and in compliance with SOPs, applicable regulations, and the principles of Good Clinical Practice. In this role, your key tasks will include: Governs quality standards for trial monitoring activities. Performs Selection, Initiation, Monitoring, and Closure Visits at Investigator Sites according to project schedule. Adheres to project guidelines and Allucent SOPs for monitoring requirements. Monitors activities at clinical study [...] Opportunity for remote/ hybrid working depending on location. Leadership and mentoring opportunities. Participation in our Buddy Program as a new or existing employee. Internal growth opportunities and career progression. Financially rewarding internal employee referral program. Access to online soft-skills and technical training via Good Habitz and internal platforms. Eligibility for our Spot Bonus Award Program in recognition of going above and [...]

Job am 02.02.2025 bei Jobleads gefunden Associate Director, Therapeutic Area Quality • Boudry, Neuenburg Führungs-/ Leitungspositionen Working with Us Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but[...]

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[...] and in their personal lives. Position Summary The Associate Director, Therapeutic Area Audit Strategy Lead will be mainly responsible for developing the TA audit strategy and overseeing the planning, conduct and reporting of internal and external audits of clinical trial investigator sites. Key Responsibilities Design, develop and implement the Clinical Audit Strategy for various Therapy Areas (ICN HOCT) . Oversee the [...] quality issues, including potential misconduct or issues of significant deviations with project/ products, to Health Authorities and RGO. Translate risk factors into Clinical Quality Assurance oversight plans, including internal and external audit strategies and inspection readiness/ management strategies. Contact appropriate technical, supervisory and management personnel internally and externally (BMS sites, vendors, partners, etc. ) in conducting and reporting of audits. Establish [...]
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Job am 01.02.2025 bei Jobleads gefunden

Sr Site Contracts Specialist Homebased Germany or Austria

• Köln, Düsseldorf, Dortmund, Nordrhein- Westfalen Sr Site Contracts Specialist Homebased Germany or Austria Updated: January 27, 2025 Location: Germany-Europe-DEU-Home-Based Job ID: 25001248 Senior Site Contracts Specialist Homebased Germany or Austria[...]

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[...] are passionate to change lives. Discover what our 29, 000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health; We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture where you [...] lead multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials. Produces site-specific contracts from country clinical trial agreement (CTA) template. Reviews and owns site-specific contracts from country template. Submits proposed CTA and investigator budget for site review. Negotiates budget and contract with site and via Site Contracts Service Centre and SSUL with Sponsor [...]
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Job am 25.01.2025 bei Jobleads gefunden Lead Medical Director Neuroscience • Basel, Basel- Stadt Führungs-/ Leitungspositionen Social network you want to login/ join with: Lead Medical Director Neuroscience, Basel Client: Location: Job Category:-Job Reference: b8b0af86ccc3 Job Views: 10 Posted: 21.01.2025 Expiry[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] interactions providing clinical science information such as the development of briefing packages and responses to HA questions with little to no supervision from more experienced Medical Directors. Collaborating with others in the development of product safety profiles, clinical sections of investigator brochures, presentations and other materials. Collaborating with relevant team members to measure and monitor study progress against objectives and plans, [...] principles and techniques of data analysis, interpretation, and clinical relevance. Experience publishing results of a scientific study in a peer-reviewed journal is preferred. Regulatory: Knowledge of medical aspects of GCP (Good Clinical Practice) , ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) , FDA, EMA, and other relevant guidelines and regulations is required. [...]

Job am 22.01.2025 bei Jobleads gefunden Postdoctoral Researcher • Wien The group of Daniela Pollak (IMP/ IMBA adjunct investigator) is seeking a highly motivated and creative Postdoctoral Researcher with a strong background in neuroscience and[...]

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The group of Daniela Pollak (IMP/ IMBA adjunct investigator) is seeking a highly motivated and creative Postdoctoral Researcher with a strong background in neuroscience and expertise in mouse optogenetics, [...] g. , iDISCO, CLARITY) and light-sheet/ confocal microscopy of large volumes. A strong publication record in relevant areas is highly desirable. Excellent communication and teamwork skills; ability to work both independently and collaboratively. Motivation to develop novel protocols and push technical boundaries in circuit neuroscience. #J-18808-Ljbffr 31554593 [...]
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Job am 10.01.2025 bei Jobleads gefunden Senior Regional Medical Advisor South Germany • Stuttgart, Baden- Württemberg Beratungs-/ Consultingtätigkeiten Senior Regional Medical Advisor South Germany Location: Stuttgart, Germany Requisition ID: 2298 # of openings: 1 Amicus Therapeutics is a global, patient-dedicated biotechnology company[...]

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[...] cross-functional alignment, the SRMA will help to execute the Medical Affairs strategy and support the German cross-functional activities for all Amicus products. The position will provide operational support for activities related to Medical Information and Communication, Medical Education and Training, Investigator Initiated Trials, and Key Opinion Leader outreach bringing value via scientific exchange. The position will also provide Research Clinical Development [...] execution at study sites as directed by internal clinical operations colleagues. Consistently collect, report and represent clinical insights and unanswered questions received from external contacts to the appropriate channels internally. Understand and effectively communicate current scientific knowledge. Build and maintain technical and clinical expertise across therapeutic areas to engage in deep scientific discussions. Engage in continuous learning within the therapeutic area. [...]

Job am 27.12.2024 bei Jobleads gefunden Sr. Clinical Research Associate (Germany) • München, Bayern At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] the trial protocol and in compliance with SOPs, applicable regulations, and the principles of Good Clinical Practice. In this role, your key tasks will include: Governs quality standards for trial monitoring activities. Performs Selection, Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule. Adheres to project guidelines and Allucent SOPs for monitoring requirements. Monitors activities at clinical study [...] Opportunity for remote/ hybrid working depending on location. Leadership and mentoring opportunities. Participation in our Buddy Program as a new or existing employee. Internal growth opportunities and career progression. Financially rewarding internal employee referral program. Access to online soft-skills and technical training via Good Habitz and internal platforms. Eligibility for our Spot Bonus Award Program in recognition of going above and [...]

Job am 07.11.2024 bei Jobleads gefunden Quality Assurance Engineer (m/f/d) • Aachen, Nordrhein- Westfalen Join us at Utimaco GmbH as a QA Engineer and take the lead in ensuring the highest quality of our innovative products Your Responsibilities As[...]

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Join us at Utimaco GmbH as a QA Engineer and take the lead in ensuring the highest quality of our innovative products Your Responsibilities As our QA Engineer (m/f/d) , you will dive deep into requirements and technical design documents, delivering sharp, actionable feedback that fuels innovation and product excellence. You will craft robust, detailed, and comprehensive test [...] automated tests using cutting-edge tools, revolutionizing our testing framework and enhancing overall productivity. You will manage a diverse range of test environments, ensuring smooth operations and consistent performance across all setups to deliver a reliable user experience. Putting on your investigator hat, you will identify, record, and track down bugs in both hardware and software, transforming obstacles into valuable opportunities for [...]
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Neu Job vor 9 Std. bei NewScientist Jobs gefunden Syneos Health Careers CRA II-Multi Sponsor-Hybrid Working • United Kingdom- Europe- GBR- Home- Based, United Kingdom Description Clinical Research Associate II Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] are passionate to change lives. Discover what our 29, 000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture-where you can [...] obtaining informed consent has been adequately performed and documented for each subject/ patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/ patient. Assesses factors that might affect subject/ patient s safety and clinical data integrity at an investigator/ physician site such as protocol deviation/ violations and pharmacovigilance issues. Per the Clinical Monitoring/ Site Management Plan (CMP/ SMP) : [...]

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