Manager, Clinical Data Management

SUMMARY:To provide management and leadership oversight of assigned teams and projects within Data Management department for study execution and budget management. Support development and implementation of Worldwide processes and initiatives.

RESPONSIBILITIES:

Tasks may include but are not limited to:

• Provide management and leadership oversight of teams and projects within Data Management department for study execution and budget management.

• To act as the primary point of contact for any study specific escalations (internal or external).

• Torepresentthe company at sponsor governance meetings.

• Manage assigned departmental personnel ensuring:

• staff areallocatedto projectsappropriatelyand according to their abilities/competencies

• appropriate oversight,trainingand mentoring is provided

• projects within the team are appropriately resourced

• operational or budget risks are discussed and addressed

• any performance related escalations for team member are managed and handled appropriately

• highlight upcoming availability to DM Management to ensure continuity of utilisation

• Define andmonitorobjectivesfor individual team members, ensuring there are opportunities for career and personal development.

• Provide support to Business Development staff byparticipatingin preparation of proposals and presentations to sponsors.​

• Participate as necessary in sponsor audits, regulatory authority inspections and otherthird partymeetings. Ensure than any recommendations are discussed and that solutions are incorporated.​

• As required, perform the role of Subject Matter Expert for a specific DM process:

• Ongoing review to ensure the process is effective and efficient.

• Central pointof contact for any related questions from the team.

• Provide ongoing training to all team members.

• Take ownership of any related Quality Issuesidentified, ensuring root cause analysis and CAPAs asrequired.

• Ownership and regular updates of related QMDs or other guidance documents.

• Provide mentorship to other members of the DM department.

• Lead and manage departmental initiatives for process improvement and efficiencies as defined by the DM Departmental leadership.

Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

OTHER SKILLS AND ABILITIES:

• Excellent attention to detail.

• Excellent written and verbal communication skills.

• Expert knowledge of data management best practices & technologies as applied to clinical trials.

• Excellent communication and interpersonal skills to collaborate with cross-functional internal and external teams.

• Advanced understanding of clinical trial process and protocols documents (protocols, statistical analysis plans, CRFs, study reports) and processes.

• Independent analytical andproblem solvingskills.

• Strong project management skills and experience managing data management teams and projects for operational and budget oversight

• Line management experience including recruitment, careerdevelopmentand performance reviews.

REQUIREMENTS:

• Bachelor’s degree or higher in biomedical sciences, life sciences, computerscienceor related discipline — or equivalent relevant experience.

• Min of 9 years of experience in clinical data management or a related role within the pharmaceutical, biotechnology, or medical device industries.

• 2-4 years of line management experience.