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clinical research associate biopharma

AstraZeneca

<div>
 At AstraZeneca, we unlock the power of what science can do. Empowered to explore, everyday we work towards our ultimate aim &ndash; treating, preventing, modifying and even curing complex diseases. With an unwavering belief in following the science, we unleash our curiosity. Investing in key areas, harnessing innovative technologies and taking smart risks. Help to shape the future of healthcare as we take our pipeline from strength to strength. Embrace an environment built on lifelong learning. Never complacent, we seek opportunities to expand our knowledge. The place to build a long-term meaningful career. Here we get to develop and grow &ndash; whether that&rsquo;s working at the leading-edge or on varied stages and molecules. Working on things that have never been done before. In return, when great science comes alive, we have the opportunity to get published. We stand together behind a shared ambition. United by our collective passion for having a positive impact on patients&rsquo; lives. Important work that is both meaningful and fulfilling. With the potential to reach over a billion patients across the globe who are living with these complex diseases.
 
 
 
 Background &amp; Qualifications
 
 
 
 <ul>
 <li>
 University degree, preferably from Healthcare related areas (Pharmacy, Veterinary, Chemistry, Biology, Medical etc. Faculties),
 </li>
 <li>
 Good level of English,
 </li>
 <li>
 Minimum 1 year of experience in a CRA and/or study coordinator positions
 </li>
 <li>
 Strong communication and negotiation skills,
 </li>
 <li>
 Ability to prioritize and handle multiple tasks,
 </li>
 <li>
 Effective planning and organizational skills with a result-oriented approach,
 </li>
 <li>
 Analytical thinking, critical reasoning ability,
 </li>
 <li>
 Good command of MS Office applications,
 </li>
 <li>
 No restriction to travel,
 </li>
 <li>
 Driving License,
 </li>
 <li>
 No military obligation for male candidates.
 
 
 </li>
 </ul>
 
 Job Description
 
 
 
 <ul>
 <li>
 Perform monitoring and site management activities for phase trials projects to assess the progress of clinical projects at assigned investigative/physician sites
 </li>
 <li>
 Ensure clinical project is conducted, recorded, and reported in accordance with the protocol, Company SOPs, ICH-GCP, and all applicable local and legal requirements.
 </li>
 <li>
 May assume clinical functional leadership tasks are assigned, actions as Lead CRA for project
 </li>
 <li>
 Train, support and advise Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
 </li>
 <li>
 Drive performance at the sites. Proactively identify and ensure timely resolution to study-related issues and escalate them as appropriate.
 </li>
 <li>
 Perform regular Site Quality Risk Assessments and adapt monitoring intensity accordingly during the study.
 </li>
 <li>
 Ensure data query resolution in a timely manner.
 </li>
 <li>
 Work with data management to ensure the robust quality of the collected study data.
 </li>
 <li>
 Collaborate with local MSLs as directed by LSM or line manager.
 
 
 </li>
 </ul>
 
 Why AstraZeneca?
 
 
 
 A high performing team, we work hard to not just meet but go beyond the needs of patients and the wider healthcare industry We leverage our partnerships with external experts across the industry, to create and communicate evidence that changes medical practice. As a partner for many, we effectively communicate complex ideas whilst seeking to understand ever-changing needs and requirements. Our valuable contribution and scientific expertise is responsible for advancing our pipeline and accelerating our pathway to finding a cure. Are you already imagining yourself joining our team? Good, because we can&rsquo;t wait to hear from you.
 
 
 
 Where can I find out more?
 
 
 
 Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
 
 
 Follow AstraZeneca on Instagram https://www.instagram.com/astrazenecaturkiyekariyer/
 
 
 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
</div>

Clinical Research Associate (Biopharma)

IQVIA

<div>Job Overview
The medical department consists of a Chief Medical Officer, Medical Directors, Sr Medical Directors, Medical Writers, and Safety Associates. The Medical Director provides medical and scientific support to clinical research programs, study teams and investigators. The Medical Director also provides review, advice, and leadership for potentially or awarded clinical research programs.
The Medical Director role is a team member participant role and functions in a matrix report to project teams much like other members of the project teams. The primary role of Medical Director is to provide medical oversight for clinical trials by serving as Medical Monitor for studies conducted by IQVIA Biotech Clinical on behalf of sponsor companies. The principal function of a Medical Monitor is to serve as primary contact for the sponsor medical team and to serve as front line medical resource to support the project team. The Medical Monitor is customarily available 24/7 to answer questions from site coordinators and investigators on protocol inclusion/exclusion criteria, protocol clarifications, and compliance issues, and to provide review of alert labs per sponsor preference. Major duties of the Medical Director are outlined below:
Essential Functions
Functions as project team member:
<ul><li>Provides medical and scientific input to clinical research programs including review of new business proposals, preclinical and/or clinical data, study protocols, training materials, informed consent, Investigator Drug Brochures, eCRFs, analysis plan designs, clinical study reports, regulatory approval submissions, serious and non-serious adverse event evaluation, and reporting.
</li><li>Ensures medical activities run according to GCP and operate with highest efficiency.
</li><li>Establishes and maintains a network of medical/scientific consultants, etc.
</li><li>Supervises and manages Medical Director activities.
</li></ul>Clinical Activities:
<ul><li>Interacts with clients regarding drug development programs, study design and protocol.
</li><li>Reviews and provides input for protocol development. Interacts with key thought leaders and/or sponsor representatives to develop inclusion/exclusion criteria and study endpoints.
</li><li>Interacts in team approach to develop statistical and data management sections of the protocol.
</li><li>Reviews the final protocol for clinical, safety and efficacy variables.
</li><li>Provides project team training on protocol and/or therapeutic areas.
</li><li>Assists team with developing criteria for investigator site selection and networking for potential investigators for study participation. Aids in review and final selection.
</li><li>Participates in subject recruitment and retention activities including individual calls to key opinion leaders, investigators, and site staff and/or participation in teleconference and WebEx presentations.
</li><li>Presents protocol and/or safety reporting information at investigator meetings.
</li><li>Develops project medical monitoring plans as requested.
</li><li>Provides on call coverage for protocol queries and site support.
</li><li>Provides first line contact for investigators and monitors regarding study related medical/safety issues and resolution of study protocol and patient eligibility issues.
</li></ul>Safety Monitoring and SAE Reporting Activities:
<ul><li>Verifies the medical accuracy of patient safety data and maintains an ongoing assessment of the safety profile of the study.
</li><li>Provides medical review of SAE reporting, writes and/or reviews SAE narratives, and works with the Safety Management Department to track SAEs and follow-up on outstanding safety queries, interacts with sponsor and discusses safety issues with site as needed.
</li><li>Reviews IND/SUSAR Safety Reports (per sponsor preference), updates to Investigator Brochures, and annual IND reports with sponsor data.
</li><li>In consultation with the sponsor, follow procedures for acquiring knowledge of subject treatment assignments (i.e. breaking the blind).
</li><li>Interact with appropriate FDA officials concerning safety and other study related issues, as requested.
</li></ul>Data Activities:
<ul><li>Provides medical review of eCRFs for clinical accuracy.
</li><li>Provides medical review of data analysis plan.
</li><li>Reviews safety fields at case freeze for reconciliation (if needed).
</li><li>Works with data group to reconcile SAE events as needed.
</li><li>Reviews medical coding of adverse events, laboratory data and concomitant medications for accuracy, coherence, consistency, and trends.
</li><li>Reviews data tables, listings, and figures.
</li><li>Reviews and/or writes portions of final clinical study report.
</li></ul>DSMB/Adjudication Committee Activities:
<ul><li>May assist sponsor in choosing committee members.
</li><li>May serve as a non-voting member to convene and organize proceedings.
</li><li>May develop operating guidelines in conjunction with committee members and submits these to sponsor for review.
</li><li>May determine data flow with sponsor to ensure reporting accuracy.
</li><li>Can ensure DSMB feedback is given to sites for IRBs.
</li><li>All DSMB activities are usually managed by the IQVIA Biotech Oversight Management Group and not the IQVIA Biotech medical monitor.
</li></ul>Business Development Activities:
<ul><li>Work with Business Development to actively solicit new business for Novella Clinical, including assistance with marketing presentations and proposal development.
</li><li>Supports business development activities with proposal development and sales presentations.
</li><li>Participates in feasibility discussions relating to specific project proposals.
</li></ul>Special Projects:
<ul><li>Obtain literature searches to acquire background information for study proposals, preparation of training sessions, and interpretation of clinical data, report writing, etc.
</li><li>Assists with drafting of standard operating procedures and working practices regarding all Medical Director activities.
</li><li>Participate in a variety of team quality improvement efforts as necessary.
</li><li>Perform other related duties as assigned or requested by the Chief Medical Officer.
</li></ul>Qualifications
<ul><li>Medical Degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education.
</li><li>10 years of experience is required which can include medical practice (hospital/clinic), academia, clinical research, or drug development.
</li><li>3-5 years of biopharmaceutical (industry) experience is preferred which can be part of the 10-year experience.
</li><li>Ability to work in partnership with a multidisciplinary group of colleagues, including translating concepts into practical approaches and promoting consensus.
</li><li>Outstanding ability to work independently with minimal supervision, ability to work effectively within a team, and matrix environment.
</li><li>Ability to organize and work efficiently on several projects, each with specific requirements and/or shifting priorities.
</li><li>Excellent oral and written communications skills as well as interpersonal skills are essential.
</li></ul>Oncology / Hematology
<ul><li>Current or prior license to practice medicine; board certification/eligibility ideal (Preference)
</li><li>Board Certified / Board Eligible: Oncology (Required)
</li></ul>IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com</div>

Medical Director - Oncology , Home- Based

<div>Job Overview 
 
Serve as Senior Data Coordinator for allocated complex studies and serve in a leadership role to a specific DM Task.
Essential Functions
<ul><li>Serve as a lead DM and the main point of contact for various projects managed by the team.
</li><li>Ensure that all the deliverables are of expected quality standards and meet customer expectations
</li><li>Attend study kick off meetings and internal/sponsor audits for assigned studies.
</li><li>Report on the quality of data collection and site issues to Data Management Team Leaders and apprise them of the status of each project.
</li><li>Interact with the Clinical Data Management personnel for project timelines, delivery of quality data and frequent project update teleconferences.
</li><li>Ensure that at the end of the study, all the Data Clarification forms are resolved, all data is &ldquo;cleaned&rdquo;, the data transfer is sent to the sponsor as per the agreed specifications, the data and the study files are completed and archived appropriately.
</li><li>Mentor other team members and ensure the completion of all required trainings.
</li><li>Assist in developing and implementing new technology / database revisions.
</li></ul>Qualifications
<ul><li>Bachelor's Degree Clinical, biological or mathematical sciences, or related field
</li><li>Clinical Data Management or Equivalent combination of education, training and experience in lieu of degree.
</li><li>Excellent organizational, communication and computer skills.
</li><li>Ability to exercise excellent attention to detail.
</li><li>Ability to act independently and with initiative required to resolving problems.
</li><li>Knowledge of Computer application- MS Office, Word and Excel
</li><li>Internet usage, Clinical application Programming /Macro knowledge will be helpful.
</li><li>Ability to establish and maintain effective working relationships with coworkers, managers and clients.
</li></ul>IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com</div>

Sr. Clin Data Coordinator

YBK in cooperation with CMS

<div>
 
 
 Company Description
 
 
 
 Yal&ccedil;&inodot;n Babal&inodot;o&gbreve;lu Kemahl&inodot; Law Firm (YBK) comprises of a team of Turkish and international lawyers offering legal counsel across diverse practice areas.
 
 
 
 
 
 Our primary focus includes Commercial, Mergers &amp; Acquisitions, Banking &amp; Finance, ESG, Energy, Capital Markets, Employment, Dispute Resolution, Corporate &amp; Restructuring, Intellectual Property, Public Procurement, and Real Estate &amp; Construction. With a deep understanding of T&uuml;rkiye's legal and business landscape, we are actively involved in some of the country's most significant transactions.
 
 
 
 
 
 
 Role Description
 
 
 
 This is a full-time on-site role for a Junior Associate located in Istanbul.
 
 
 
 
 
 
 Qualifications
 
 
 <ul>
 <li>
 Bachelor's degree in law or related field from a well-reputed university;
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 Minimum of two years&rsquo; professional experience, ideally including corporate, compliance, or competition law;
 </li>
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 Strong research and analytical skills with attention to detail;
 </li>
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 Excellent written and verbal communication skills in Turkish and English;
 </li>
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 Effective multitasking abilities;
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 Team player with a desire to learn and grow;
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 Proficiency in Microsoft Office (Word, Excel, PowerPoint) and legal research tools;
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 Self-motivated, proactive, and eager to contribute.
 </li>
 </ul>
 
 
 
 
 
 How to Apply:
 
 
 
 If you're interested, please send your CV, English qualification test results, and a cover letter to
 
 info@ybk-av.com
 
 .
 
</div>

Junior Associate

Kedrion Biopharma

<div>
 
 Kedrion Biopharma is a biopharmaceutical company specializing in the development, production and distribution of plasma-derived products. Kedrion has been producing plasma products for over 40 years and has a market presence in about 100 countries. Our employees are committed to the highest standards and therapies for the patients and clinicians in haematology, immunology, neurology, and transfusion medicine.
 
 
 
 
 
 We're looking for a
 
 Scientific Services Manager,
 
 to join our team in Istanbul or Ankara.
 
 
 
 
 
 
 Role Purpose:
 
 
 
 Scientific Service is the Responsible Person in charge of information on medicines which the Company puts on the market. Serves as technical and scientific reference, providing accurate, timely, fair-balanced medical information internally within Company and to external customers.
 
 
 He/She is responsible for fulfilling requirements for the Scientific Service role, according to the EU Directive 2001/83/EC in general and the local laws.
 
 
 
 
 
 
 Main Responsibilities:
 
 
 
 
 
 <ul>
 <li>
 Compiling and collating all information received from any source concerning the medicines that the Company puts on the market.
 </li>
 <li>
 Ensuring that product advertisements correspond to the content of the current effective marketing authorization/registration and comply with Turkey legal requirements for advertising and promotion, as well as Company procedures and policies.
 </li>
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 Ensuring that regulations on advertising &amp; promotion, external communication and interaction with healthcare professionals by the Company sales representatives are promptly implemented.
 </li>
 <li>
 Manages unsolicited requests for medical information from external customers (including product requests for unlicensed products in Turkey), in alignment with international best practices and Company policies and procedures.
 </li>
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 Reviews and approves evidence-based, balanced Medical Response Documents (MRDs) such as Standard Response Letters (SLRs) and Frequently Asked Questions (FAQs) dedicated to Turkey, ensuring compliance with local regulations.
 </li>
 <li>
 Reviews and approves Summary of Products Characteristics (SmPC) for products commercialized in the Country.
 </li>
 <li>
 Ensures records of medical inquiries, advertising &amp; promotion review/approval process, sales representatives training, in compliance with applicable regulations, Company policies and procedures.
 </li>
 <li>
 Maintains global interactions, mainly with Italy, relating to compliance with regulations for advertising &amp; promotion, therapeutic and medical information, and reporting activities.
 </li>
 <li>
 Responsible for setting up local procedures for the management of medical and scientific activities (Medical Inquiries Management, Promotional Material review, Scientific Training Management, etc.).
 </li>
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 Responsible for providing information and assistance to Regulatory Authorities, and for ensuring the decisions taken by the authorities or bodies responsible for monitoring advertising of medicinal products are immediately and fully complied with.
 </li>
 </ul>
 
 
 
 
 
 Requirements:
 
 
 
 
 
 <ul>
 <li>
 Professional experience in related fields of at least two years.
 </li>
 <li>
 Professional experience in quality management in pharmaceutical industry.
 </li>
 <li>
 Written and spoken fluency in Turkish and English.
 </li>
 <li>
 Education: university studies degree in the field of pharmacy
 </li>
 <li>
 Place of residence: Turkey
 </li>
 </ul>
</div>

Scientific Services Manager

Sanofi

<div>Job Title: Field Medical Manager - Immunology/Respiratory
Location: Istanbul
About the Job
The Field Medical Manager is a field-based medical professional responsible for engaging with Key Opinion Leaders (KOLs), Health Care Professionals (HCPs), and regional/local institutions through high-level scientific exchange. This includes medical education, research collaboration, publications, consultancy, and other Medical Affairs initiatives aligned with company strategy.
Main Responsibilities<ul><li>
Establish and maintain scientific relationships with KOLs, HCPs, and relevant institutions in the assigned territory.</li><li>
Actively contribute to training programs, research projects, publications, and consultancy activities.</li><li>
Facilitate effective cross-functional communication to support the implementation of Medical Affairs strategies.</li><li>
Provide comprehensive medical and scientific support across internal teams.</li><li>
Represent Sanofi as a &ldquo;Scientific Ambassador&rdquo; in all external engagements.</li></ul>
About You<ul><li>
University degree from medicine or pharmacy is required.</li><li>
Prior experience in the pharmaceutical industry and in Immunology is desired.</li><li>
Fluent in Turkish and English (both verbal and written).</li><li>
Must be able to travel extensively.</li><li>
Excellent communication skills, including verbal, written, and public speaking abilities.</li><li>
Strong ability to analyze and interpret clinical and preclinical data.</li><li>
Collaborative mindset with a strong ability to work in cross-functional teams.</li><li>
Proactive and solution-oriented approach in a dynamic medical environment.</li><li>
Demonstrated ability to build and maintain strong relationships with both external and internal stakeholders.</li><li>
Driver's license is a must.</li></ul>
null</div>

Field Medical Manager - Immunology/Respiratory

AbbVie

<div>Company Description 
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas &ndash; immunology, oncology, neuroscience, and eye care &ndash; and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. 
Job Description 
 We are looking for team members who located Istanbul or Ankara.<ul><li>
Provide scientific and technical leadership to ensure professional and credible relationships with thought leaders and external experts of strategic importance to AbbVie.</li><li>
Ensure a strong medical and scientific presence for AbbVie in key academic centers by facilitation of research and educational initiatives, while supporting requests for medical and scientific information on products or areas of therapeutic interest to AbbVie.</li><li>
Support internal teams such as sales and marketing and members of the Affiliate Brand Team to develop their scientific and technical expertise through the delivery of scientific up-to-date presentations. Work collaboratively and cross-functionally with other in-field members while retaining functional independence.</li><li>
Attend relevant scientific meetings and Conferences. Collaborate with internal stakeholders to develop summaries of key data and other scientifically relevant information to inform AbbVie strategic priorities and initiatives.</li><li>
Develop and maintain collaborative relationships with thought leaders in the product / therapeutic area for which the MSL has been assigned responsibility, to facilitate AbbVie research and educational priorities and strategic initiatives.</li></ul> 

Qualifications 
<ul><li>
University degree in Medicine or Pharmacy,</li><li>
Previous experience in academy and/or pharma industry would be an asset</li><li>
Fluency in English,</li><li>
Experience in developing and maintaining expert knowledge for the assigned therapeutic area, and in medical research in general,</li><li>
Solid knowledge of the pharmaceutical environment and the role of Medical Affairs to advance the medical and scientific objectives of a pharmaceutical company,</li><li>
Demonstrated expertise in the scientific methods applied to clinical research and current legislative/regulatory controls applicable to this research.</li></ul> 

Additional Information<div></div> 
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US &amp; Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html</div>

Medical Science Liaison

Explore 212+ Clinical research associate biopharma in Istanbul this October. Find roles across top companies and apply now to boost your career.