Manager, Clinical Data Management

Worldwide Clinical Trials • Sacramento, CT

1d • Onsite

About The Position

This role provides management and leadership oversight of assigned teams and projects within the Data Management department for study execution and budget management. The position supports the development and implementation of Worldwide processes and initiatives. The company is a global, midsize CRO that focuses on innovative and pioneering approaches to developing cures for diseases. They emphasize a collaborative, diverse, and inclusive environment where employees can thrive and do their best work.

Requirements

• Bachelor’s degree or higher in biomedical sciences, life sciences, computer science or 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.
• 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 and problem solving skills.
• Strong project management skills and experience managing data management teams and projects for operational and budget oversight.
• Line management experience including recruitment, career development and performance reviews.

Responsibilities

• Provide management and leadership oversight of teams and projects within Data Management department for study execution and budget management.
• Act as the primary point of contact for any study specific escalations (internal or external).
• Represent the company at sponsor governance meetings.
• Manage assigned departmental personnel ensuring staff are allocated appropriately, receive adequate oversight, training and mentoring, projects are resourced, operational or budget risks are addressed, and performance escalations are managed.
• Highlight upcoming availability to DM Management to ensure continuity of utilization.
• Define and monitor objectives for individual team members, ensuring opportunities for career and personal development.
• Provide support to Business Development staff by participating in proposal preparation and sponsor presentations.
• Participate as necessary in sponsor audits, regulatory authority inspections, and other third-party meetings, ensuring recommendations are discussed and solutions incorporated.
• Perform the role of Subject Matter Expert for a specific DM process, including ongoing review for effectiveness and efficiency, acting as a central contact for questions, providing ongoing training, taking ownership of Quality Issues, and updating related guidance documents.
• Provide mentorship to other members of the DM department.
• Lead and manage departmental initiatives for process improvement and efficiencies as defined by DM Departmental leadership.
• Perform other duties as assigned.

Benefits

• Competitive benefits package depending on location.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager