Senior Manager, Clinical Data Management & Strategy

Worldwide Clinical Trials; Hartford (CT); On-site; USD 99,000 - 196,000; Full time

Job summary

Worldwide Clinical Trials is seeking a senior Data Management leader to provide management and oversight of assigned teams and projects across study execution and budget management. You will act as the primary escalation point, represent the company at sponsor governance meetings, and ensure resources and mentoring for team members.

The role requires extensive data management expertise, leadership experience, and the ability to drive process improvements within the DM department.

Qualifications

• Bachelor’s degree or higher in biomedical sciences, life sciences, computer science or related discipline.
• 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.

Responsibilities

• 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).
• To represent the company at sponsor governance meetings.
• Manage assigned departmental personnel ensuring staff are allocated to projects appropriately and according to their abilities/competencies.
• Provide appropriate oversight, training and mentoring.
• Ensure projects within the team are appropriately resourced.
• Discuss and address operational or budget risks.
• Manage and handle any performance related escalations for team member appropriately.
• Highlight upcoming availability to DM Management to ensure continuity of utilisation.
• Define and monitor objectives for individual team members, ensuring opportunities for career and personal development.
• Provide support to Business Development staff by participating in preparation of proposals and presentations to sponsors.
• Participate as necessary in sponsor audits, regulatory authority inspections and other third party meetings. Ensure that 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 point of contact for any related questions from the team.
• Provide ongoing training to all team members.
• Take ownership of any related Quality Issues identified, ensuring root cause analysis and CAPAs as required.
• 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.

Skills

Attention to detail

Communication skills

Analytical thinking

Project management

Team leadership

Education

Bachelor’s degree or higher in biomedical sciences, life sciences, computer science or related discipline

Job description

Worldwide Clinical Trials is seeking a senior Data Management leader to provide management and oversight of assigned teams and projects across study execution and budget management. You will act as the primary escalation point, represent the company at sponsor governance meetings, and ensure resources and mentoring for team members.

The role requires extensive data management expertise, leadership experience, and the ability to drive process improvements within the DM department.