Job Description
Position: Clinical Research Data Manager
Company: Merck & Co., Inc. (MSD)
Location: Mahdia, Tunisia
Experience: 5+ years in clinical data management within pharmaceutical or CRO environment
Education: Bachelor’s or Master’s degree in Life Sciences, Biostatistics, Computer Science, or related field
Employment Type: Full-time
Industry: Pharmaceutical Research & Clinical Trials
Department: Global Clinical Development Operations
Vacancies:1
Company Overview
Merck & Co., Inc., known as MSD outside the United States and Canada, is a leading global biopharmaceutical company committed to inventing for life. For over 130 years, we have brought forward medicines and vaccines for many of the world’s most challenging diseases. Our Tunisian operations are a critical hub for clinical research and development in the MENA region, focusing on advancing therapeutic innovations that improve and extend lives. We are dedicated to high standards of ethics and integrity, and we invest significantly in research and development to deliver transformative health solutions. Joining MSD in Tunisia means becoming part of a diverse, inclusive team that values collaboration and scientific excellence, offering unparalleled career opportunities in Tunisia within a globally respected organization.
Job Overview
We are seeking a meticulous and experienced Clinical Research Data Manager to join our Global Clinical Development Operations team in Mahdia. This role is central to ensuring the integrity, quality, and compliance of clinical trial data, which forms the foundation of our regulatory submissions and scientific publications. You will be responsible for the end-to-end data management activities for assigned clinical studies, collaborating closely with cross-functional teams including Biostatistics, Clinical Operations, and Medical Writing. This position represents a vital job vacancy in Tunisia for professionals passionate about contributing to life-saving research in a dynamic, data-driven environment. You will utilize advanced data management systems and methodologies to support our portfolio of clinical trials across various therapeutic areas. For more jobs in Tunisia across different sectors, visit https://tunisiajobsearch.com.
Key Responsibilities
- Develop and review data management documents including Data Management Plans (DMPs), Case Report Form (CRF) completion guidelines, and data validation specifications.
- Oversee the design and validation of clinical databases and electronic data capture (EDC) systems in collaboration with vendors and internal IT teams.
- Manage the data cleaning and discrepancy management process, ensuring timely and accurate query resolution with clinical sites.
- Perform quality control checks and reconciliation of clinical data against other data sources (e.g., laboratory, safety).
- Generate and review data listings and metrics to monitor data quality and study progress, presenting findings to study teams.
- Lead database lock activities, ensuring all data management tasks are completed for timely and accurate database locks.
- Ensure compliance with company Standard Operating Procedures (SOPs), ICH-GCP guidelines, and relevant regulatory requirements for data management.
- Serve as the primary data management contact for assigned studies, providing expertise and support to internal and external stakeholders.
- Contribute to the development and implementation of data management process improvements and new technologies.
Required Skills
- Expert knowledge of clinical data management processes, standards (CDISC), and electronic data capture (EDC) systems such as Medidata RAVE, Oracle Clinical, or Veeva.
- Strong understanding of clinical trial protocols, medical terminology, and ICH-GCP guidelines.
- Proficiency in data review tools and programming languages such as SAS, SQL, or Python for data review and reporting.
- Excellent analytical, problem-solving, and organizational skills with a keen attention to detail.
- Proven ability to manage multiple priorities in a fast-paced, deadline-driven environment.
- Strong communication and interpersonal skills for effective collaboration with global and local teams.
- Leadership capabilities with experience in mentoring junior staff or leading data management aspects of a study.
Education
A Bachelor’s or Master’s degree in Life Sciences, Biostatistics, Computer Science, Information Management, or a closely related scientific/technical field is required. Advanced certifications in clinical data management (e.g., CCDM) are highly desirable.
Experience
A minimum of 5 years of hands-on experience in clinical data management within the pharmaceutical industry or a Contract Research Organization (CRO) is essential. Candidates must have demonstrated experience with the full data management lifecycle from study start-up to database lock for Phase I-IV clinical trials. Experience working on global studies and with diverse therapeutic areas is a strong advantage.
Benefits
- Competitive salary and comprehensive benefits package aligned with global standards.
- Performance-based annual bonus and long-term incentive plans.
- Extensive health, dental, and life insurance coverage for employees and dependents.
- Generous paid time off, including vacation, sick leave, and company holidays.
- Retirement savings plan with company matching contributions.
- Continuous professional development through training programs, conferences, and tuition assistance.
- Flexible working arrangements and support for work-life balance.
- Access to on-site wellness programs and employee assistance services.
Training
- Comprehensive onboarding program covering company processes, systems, and therapeutic area knowledge.
- Ongoing technical training on advanced data management systems, CDISC standards, and regulatory updates.
- Leadership and soft skills development programs for career advancement.
- Opportunities for international job rotations and assignments to gain global experience.
- Sponsorship for professional certification programs in clinical data management.
Working Environment
You will work in a modern, collaborative office in Mahdia that fosters innovation and teamwork. Our environment is built on mutual respect, scientific curiosity, and a shared mission to save and improve lives. You will be part of a supportive, multicultural team with access to cutting-edge technology and resources. We promote a culture of continuous learning and provide a platform for meaningful contributions to global health challenges, making this a premier destination for employment in Tunisia in the pharmaceutical sector.
Application Process
Qualified candidates are invited to submit their updated CV and a cover letter through our official careers portal. The process includes an initial screening, followed by interviews with the hiring manager and key team members, and potentially a technical assessment. We are committed to a transparent and efficient hiring in Tunisia process. For other opportunities in the region, you may also explore https://www.eswatinijobsearch.com/.
Equal Opportunity Statement
MSD is an equal opportunity employer committed to fostering a diverse and inclusive workforce. All qualified applicants will receive consideration for employment in Tunisia without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. We believe diversity drives innovation and are dedicated to creating a workplace where everyone can contribute their best.