Job Description
Summary The Clinical Data Management Manager/Director will lead and oversee all clinical data management activities to ensure data accuracy, completeness, and compliance, supporting clinical research and product development objectives. Reporting to the Head of the Clinical Science Department, this role will play a pivotal role in clinical studies and product development processes.
Education and Experience - MS in Biostatistics/Statistics/Computer Science/Biology/Pharmacy or related field, PhD is preferred
- 5-15 years of experience in data management, preferably in clinical research or biotechnology.
- Proven experience leading teams and managing multiple projects simultaneously.
Skills and Qualifications - In-depth understanding of clinical research methodologies and ability to implement them effectively.
- Strong problem-solving skills with the ability to provide technical solutions for complex challenges.
- Expertise in clinical study design concepts, drug regulations, and management of data management functions.
- Preferred: Certifications in clinical data management (e.g., CDISC, SCDM) and proficiency in data management tools and workflows.
- Familiarity with regulatory guidelines (e.g., GCP, FDA, EMA) and requirements related to statistical analysis, study reporting, and regulatory submissions.
- Ability to manage multiple projects, allocate limited resources efficiently, and deliver high-quality results on time while adapting to shifting priorities.
- Excellent written, verbal, and interpersonal communication skills, with the ability to collaborate effectively in cross-functional, non-data managing environments.
Responsibilities - Develop and implement data management strategies for clinical trials.
- Collaborate with external vendors in data management function to ensure adherence to timelines and quality standards.
- Oversee the design, development, and validation of data collection tools (e.g., CRFs, eCRFs) and databases.
- Ensure compliance with regulatory standards (e.g., GCP, FDA, EMA) and industry best practices.
- Collaborate with cross-functional teams (e.g., Clinical Operations, Clinical Science) to support study objectives.
- Serve as the primary point of contact for data management-related inquiries and audits.
- Monitor data entry, cleaning, and validation processes to guarantee data accuracy and integrity.
- Establish and maintain standard operating procedures (SOPs) for data management activities.
- Provide training on data management processes and requirements to internal teams and external partners.
- Liaise with clinical researchers to identify and deliver statistical support aligned with development strategies (with a focus on data management support).
Job Tags
Full time, Shift work,