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clinical research manager

Fortrea

<div></div><div><div>Fortrea is recruiting an experienced Clinical Project Manager with valuable expertise in Oncology. In this role, you will ensure the successful execution of clinical studies on a local level, while maintaining high-quality standards and regulatory compliance. This position is sponsor-dedicated for a renowned pharmaceutical company.<div><div><div><div><div><div><div><div><div><h3 class="jobSectionHeader">
Please note this role is for upcoming future opportunities that may arise at Fortrea.
</h3></div></div></div></div></div></div></div></div></div></div>Summary of Responsibilities:<ul><li>
Leading the local study teams (consisting of monitors and study administrators) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines</li><li>
Ensuring that study sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived</li><li>
Ensuring timely submissions of proper application/documents to Ethic Committee/Regulatory Authority.</li><li>
Close communication with global study teams and overall responsibility for study commitments, for timely delivery of data to required quality as agreed with global</li><li>
Creating and implementing alternative action plans proactively in order to reach the targeted patient numbers; monitoring the patience admission processes in coordination with the researchers; planning and taking the necessary precaution when required</li><li>
Ensuring the compliance of the clinical research process with ICH-GCP practices, the study protocol, Global and Local Clinical SOP&rsquo;s, and the Ministry of Health Clinical Research Regulations; being knowledgeable about these procedures and keeping abreast of any changes and revision</li><li>
Participating in system/process improvement projects within global and local task groups consisting of employees from different units</li></ul>
Qualifications:<ul><li>
University degree, preferably from Healthcare related areas (Pharmacy, Veterinary, Chemistry, Biology, Medical etc. Faculties),</li><li>
Advanced level of English,</li><li>
Minimum 5 year experiences in Clinical Research (preferably 2 years in Project Management positions and Oncology specific)</li><li>
Project management skills,</li><li>
Strong communication and negotiation skills,</li><li>
Ability to prioritize and handle multiple tasks,</li><li>
Basic coaching skills and good at team work,</li><li>
Financial management skills,</li><li>
Effective planning and organizational skills with result-oriented approach,</li><li>
Stakeholder management experience,</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></ul>
Learn more about our EEO &amp; Accommodations request here.</div>

Clinical Project Manager sponsor-dedicated

Exeltis Turkey

<div>
 
 
 Medical Manager
 
 
 
 
 
 
 We are looking for a Medical Manager to be assigned to our Head Office at Exeltis Turkey.
 
 
 
 
 
 
 Qualifications
 
 
 <ul>
 <li>
 Medical Doctor (MD) degree,
 </li>
 <li>
 Excellent command of written and spoken English,
 </li>
 <li>
 Proficient in MS Office applications and effective presentation techniques,
 </li>
 <li>
 Strong sense of responsibility with analytical and strategic thinking skills,
 </li>
 <li>
 Holder of a valid B-class driving license and actively driving,
 </li>
 <li>
 No restrictions on travel.
 </li>
 <li>
 Experience in Respiratory Field will be preferred
 </li>
 </ul>
 
 
 
 
 
 Job Description
 
 
 <ul>
 <li>
 Providing continuous medical update and support for existing products,
 </li>
 <li>
 Represent the company at Scientific Congresses, trainings, and medical meetings,
 </li>
 <li>
 Provide medical support to Marketing and Sales teams during scientific presentations,
 </li>
 <li>
 Contribute medical insights to product strategies,
 </li>
 <li>
 Conduct meetings with key opinion leaders (KOLs) and Health Authorities regarding assigned products,
 </li>
 <li>
 Plan, initiate, and monitor clinical research activities,
 </li>
 <li>
 Oversee pharmacovigilance operations and ensure the pharmacovigilance system remains compliant with current regulatory requirements
 </li>
 </ul>
 
 
</div>

Medical Manager

Audubon Bioscience

<div>
 
 Goal
 
 
 
 The goal of this role is to elevate the CRO&rsquo;s operations in T&uuml;rkiye (and potentially the Middle East region),
 
 
 driving the strategic growth of the clinical partner network, providing strong leadership to the local team,
 
 
 and ensuring the timely and efficient execution of research projects&mdash;particularly in lung cancer.
 
 
 
 Job Duties
 
 
 
 <ul>
 <li>
 Business and Operations Leadership
 </li>
 <li>
 Act as Audubon&rsquo;s representative in T&uuml;rkiye
 </li>
 <li>
 Develop and execute yearly business plan (own P&amp;L)
 </li>
 <li>
 Negotiate and sign contracts
 </li>
 <li>
 Conduct budget planning and oversee payments
 </li>
 <li>
 Partnerships and Growth
 </li>
 <li>
 Know and network with national opinion leaders in lung cancer
 </li>
 <li>
 Build and manage relationships with clinics/labs, doctors, vendors
 </li>
 <li>
 Identify and onboard new partners to support project demand
 </li>
 <li>
 Regulatory and Quality
 </li>
 <li>
 Obtain Ethics Approvals and Ministry of Health permissions
 </li>
 <li>
 Ensure compliance with relevant regulations, ethics approvals, and licenses
 </li>
 <li>
 Collaborate with Audubon&rsquo;s Quality and Legal/Regulatory teams
 </li>
 <li>
 People and Training
 </li>
 <li>
 Hire, manage, and mentor local staff
 </li>
 <li>
 Support and guide local Country Manager
 </li>
 <li>
 Train site staff and medical personnel
 </li>
 <li>
 Project Execution
 </li>
 <li>
 Oversee biosample and data collection accuracy
 </li>
 <li>
 Implement Audubon&rsquo;s processes and e-systems locally
 </li>
 <li>
 Maintain a secure, up-to-date operational database
 </li>
 <li>
 Science
 </li>
 <li>
 Generate relevant scientific research projects
 </li>
 <li>
 Develop and coordinate scientific collaborations
 </li>
 <li>
 Contribute to publications and presentations
 
 
 </li>
 </ul>
 
 Requirements
 
 
 
 <ul>
 <li>
 Education in the fields of medicine, pharmacology or biology.
 </li>
 <li>
 Additional education in business areas is a significant plus.
 </li>
 <li>
 Experience in the medical business with competencies in management skills and operational planning &ndash; at least 5 years in the position of manager.
 </li>
 <li>
 Balanced ambitiousness and target-oriented approach. Eager for professional growth.
 </li>
 <li>
 Excellent oral and written communication skills for negotiations and presentations.
 </li>
 <li>
 Self-organization, creativity, analytical skills, and the ability to complete tasks on time.
 </li>
 <li>
 Management and leadership skills (particularly capability to set tasks for the team and track their execution, distribute responsibilities, delegate authority).
 </li>
 <li>
 English language at upper-intermediate level or higher. Turkish language &ndash; native.
 </li>
 <li>
 Willingness to take business trips within T&uuml;rkiye (mostly) and internationally as needed.
 </li>
 <li>
 Strong IT user skills: knowledge of Windows, MS Office, and Google Suite.
 
 
 </li>
 </ul>
 
 The Company Offers
 
 
 
 <ul>
 <li>
 Full-time position in a fast-growing business of biotechnology
 </li>
 <li>
 Excellent professional and career opportunities
 </li>
 <li>
 Open-minded executive management
 </li>
 <li>
 Market compensation (salary and bonuses)
 </li>
 <li>
 Private Health Insurance
 </li>
 <li>
 Fully paid vacation and sick leave
 </li>
 </ul>
</div>

Turkiye Regional Director

Eli Lilly

<div>At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We&rsquo;re looking for people who are determined to make life better for people around the world.<h3 class="jobSectionHeader">
Overview</h3>
The Clinical Research Lead (CRL) is responsible for managing clinical investigators and sites participating in Lilly clinical trials and/or Post-Marketing Safety Studies. This includes investigator/site identification and qualification, ensuring timely trial enrollment aligned with scientific objectives, database lock delivery, issue resolution at trial sites, and maintaining inspection readiness at all times.
The CRL ensures global program delivery through comprehensive investigator and site management, leveraging data and tools for informed decisions, and fostering high-quality interactions with clinical trial sites to provide an unparalleled customer experience. Additionally, the CRL oversees vendor monitoring activities, identifying and mitigating significant findings and trends.
In countries without an Associate Director/Director of Investigator Engagement, the CRL may represent Investigator Engagement internally and externally, including interactions with regulatory bodies and influencing the local regulatory environment and strategy.<h3 class="jobSectionHeader">
Primary Responsibilities</h3>
Clinical Investigator Management<ul><li>
Manage all activities at clinical trial sites, including site identification, qualification, enrollment planning, execution, and close-out.</li><li>
Ensure timely delivery of enrollment readiness, trial recruitment, and database locks through performance management and issue resolution.</li><li>
Identify opportunities to accelerate trial enrollment while maintaining an exceptional customer experience.</li><li>
Apply scientific, therapeutic area, and regional expertise to support trial execution and quality data delivery.</li><li>
Develop strategic institutional/site relationships to optimize clinical trial programs across therapeutic areas.</li></ul>
Clinical Trial Management<ul><li>
Implement investigator/site risk plans to meet enrollment and database lock commitments.</li><li>
Maintain site and country-level inspection readiness at all times.</li><li>
Use metrics to inform site/country/regional decision-making.</li><li>
Collaborate with internal and external teams to remove barriers to trial execution.</li><li>
Understand local treatment paradigms and standard of care to support feasibility and trial allocation.</li><li>
Provide vendor oversight for site monitoring activities.</li><li>
For countries with PMS requirements: manage Post-Marketing Safety Studies, including CRO selection, regulatory documentation, and project management.</li></ul>
Business Management and Engagement<ul><li>
Build strong professional relationships with clinical investigators to expand research partnerships and deliver an exceptional trial experience.</li><li>
Collaborate cross-functionally to align priorities and deliver the portfolio.</li><li>
Prospect targeted sites in line with portfolio strategy.</li><li>
Maintain therapeutic and technical expertise for scientific discussions with investigators and site staff.</li><li>
Act as a communication bridge between sites, vendors, and Lilly.</li><li>
Influence internal and external factors to improve clinical research delivery.</li></ul>
Country/Regulatory Responsibilities (where applicable)<ul><li>
Engage with regulatory bodies, ethical review boards, and national authorities to represent Lilly in the clinical trial environment.</li><li>
Participate in country pharmaceutical associations and affiliated bodies.</li><li>
Ensure compliance with local regulatory requirements and maintain internal processes accordingly.</li><li>
Contribute to external clinical development community initiatives and incorporate learnings into internal strategies.</li><li>
Support affiliate leadership in implementing regional initiatives.</li></ul><h3 class="jobSectionHeader">
Minimum Qualifications</h3><ul><li>
Bachelor&rsquo;s degree or equivalent (preferably in a scientific or health-related field).</li><li>
Minimum 3 years of experience in pharmaceutical industry and/or clinical research.</li><li>
Strong knowledge of Good Clinical Practice (GCP).</li><li>
Ability to acquire and maintain therapeutic expertise to support portfolio needs.</li><li>
Excellent organizational and self-management skills.</li><li>
Strong communication skills (verbal and written) and ability to influence others.</li><li>
Strategic agility and broad business acumen.</li><li>
Demonstrated leadership behaviors and ability to lead in uncertain environments.</li></ul><h3 class="jobSectionHeader">
Additional Preferences</h3><ul><li>
Strong organizational and planning skills.</li><li>
Ability to enhance customer experience.</li><li>
Fluent in English.</li><li>
Knowledge of country regulatory guidelines.</li><li>
Strong teamwork and interpersonal skills.</li><li>
Ability to develop innovative solutions.</li><li>
Travel required (50&ndash;75%).</li></ul>
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
#WeAreLilly</div>

Clinical Research Lead

<div>At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We&rsquo;re looking for people who are determined to make life better for people around the world.
Ensure compliance with local Good Clinical Practice (GCP) Quality System as well as compliance with applicable T&uuml;rkiye MOH regulations.
Technical training, personal skills and experience required:<ul><li>
A university degree in Pharmacy from T&uuml;rkiye.</li><li>
Minimum 2 years&rsquo; experience in quality assurance applied to the pharmaceutical industry.</li><li>
Working knowledge of GCP regulations and quality system implementation and the ability to interpret and apply them for Quality Assurance (QA) responsibilities</li><li>
Fluent in English (conversational, writing and reading) Knowledge and mastery of basic computing tools (Microsoft office).</li><li>
Good interpersonal relations Ability to train working groups.</li><li>
Good analytical skills and attention to details.</li><li>
High initiative, learning agility and a flexible, positive attitude.</li><li>
High degree of accuracy and attentive to details.</li></ul>
The Responsible Manager Delegate for Clinical Trial Materials is responsible for:<ul><li>
Act as delegated Responsible Manager to Perform Quality checks for the release of the Clinical Trial Products upon arrival to T&uuml;rkiye.</li><li>
Release clinical trial product shipments that meet all quality specifications and local regulations as a delegated Responsible Manager.</li><li>
Support inspection readiness activities for MOH inspections. Assure that deviations, change management processes, root cause investigations, and corrective/preventive actions are effectively managed, documented, escalated, and completed in a timely manner.</li><li>
Monitor compliance with the external party which is responsible for storage and distribution of Clinical Trial Materials.</li><li>
Assist on training programs to external vendors which might have impact on Clinical Trial Material operations.</li><li>
Review the returned products, ensure that any potential quality issue or failure that could have originated the return will be reported appropriately and coordinate if new provision applies to these products Support Quality Manager on reviewing/ updating Quality Agreements related to Clinical Trial Products Act as a point of contact for quality release of clinical trial materials in T&uuml;rkiye affiliate.</li><li>
Provide appropriate escalation of issues clinical teams and affiliate Responsible Manager.</li><li>
Understand performance metrics related to CT material and identify areas for improvement and simplification.</li><li>
Understand SOPs and processes for CT materials.</li></ul>
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
#WeAreLilly</div>

Junior Responsible Manager Delegate for Clinical Trial Materials

Parexel

<div>Key Accountabilities:<div><div><div><div><div><div><div><div><div>
Site Management Responsibilities<ul><li>
Contributes to the selection of potential investigators.
</li><li>In some countries, as required, Sr CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
</li><li>Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
</li><li>Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are always inspection ready.
</li><li>Actively participates in Local Study Team (LST) meetings.
</li><li>Contributes to National Investigators meetings, as applicable.</li><li>
Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST.
</li><li>Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
</li><li>Updates CTMS and other systems with data from study sites as per required timelines.
</li><li>Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.</li><li>
Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSAD the correct timing and type of visits.
</li><li>Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.
</li><li>Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
</li><li>Ensures data query resolution in a timely manner.
</li><li>Works with data management to ensure robust quality of the collected study data.
</li><li>Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.</li><li>
Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP.
</li><li>Follows up on outstanding actions with study sites to ensure resolution in a timely manner.
</li><li>Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required.
</li><li>Assists site in maintaining inspection ready ISF.
</li><li>Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD).
</li><li>Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate.
 </li><li>Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF.
</li><li>Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
</li><li>Collaborates with local Medical Scientific Liaisons (MSLs) as directed by LSAD or line manager</li></ul>
Compliance with Sponsor Standards<ul><li>
Ensures compliance with the Client&rsquo;s Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment).</li><li>
Ensures compliance with local, national, and regional legislation, as applicable.
</li><li>Completes timesheets accurately as required</li></ul>
Compliance with Parexel Standards<ul><li>
Complies with required training curriculum.
</li><li>Completes timesheets accurately as required.
</li><li>Submits expense reports as required.
</li><li>Updates CV as required.
</li><li>Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements.</li></ul>
Skills (Essential):
<ul><li>Excellent attention to detail.
</li><li>Good written and verbal communication skills.
</li><li>Good collaboration and interpersonal skills.
</li><li>Good negotiation skills.
</li><li>Proficient in written and spoken English language required.
</li><li>Fluency in local language(s) required.
</li></ul>Skills (Desirable):
<ul><li>Ability to work in an environment of remote collaborators. Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.
</li><li>Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
</li><li>Good analytical and problem-solving skills.
</li><li>Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
</li><li>Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.
</li><li>Team oriented and flexible; ability to respond quickly to shifting demands and opportunities Knowledge and Experience (Essential):
</li><li>Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. &bull; Good knowledge of relevant local regulations.
</li><li>Good medical knowledge and ability to learn relevant Client Therapeutic Areas.
</li><li>Basic understanding of the drug development process.
</li><li>Good understanding of Clinical Study Management including monitoring, study drug handling and data management.</li></ul>
Knowledge and Experience (Desirable):
<ul><li>Familiar with risk-based monitoring approach including remote monitoring.
</li><li>Good cultural awareness.
</li></ul>Education:
<ul><li>Bachelor&rsquo;s degree in related discipline, preferably in life science, (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.</li></ul>
Other:<ul><li>
Ability to travel nationally/internationally as required.
</li><li>Valid driving license per country requirements, as applicable</li></ul></div></div></div></div></div></div></div></div></div></div>

Senior Clinical Research Associate & CRAII - FSP (Open)

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 are 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
 
 
 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

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