[Hiring] Associate Director, Clinical Data Management @Worldwide Clinical Trials

Role Description

Oversee the management team to ensure compliance with SOPs on assigned project and team project and budget oversight. Support the development and implementation of department initiatives. Provide leadership, managerial, and technical expertise to the Data Management department, ensuring the efficient, accurate, and timely completion of Data Management deliverables.

Responsibilities:

• Ensure that all operations carried out by department are conducted to applicable regulations, GCP, Worldwide SOPs and guidelines, and to the requirements of the sponsor.
• Provide line management for assigned management team.
• Define and monitor objectives for assigned Managers, ensuring there are opportunities for career and personal development.
• Contribute to the strategic management of the department.
• Oversee resourcing for assigned team ensuring proactive and strategic assignment of resources.
• Oversee departmental quality and issue management by proactively identifying trends and initiation of strategic solutions.
• Manage overall departmental project deliverables by proactively reviewing project status and establishing mitigation plans.
• Proactively monitor and manage project profitability and overburn/underburn for department projects.
• Oversee Subject Matter Experts to ensure effective process oversight.
• Provide departmental oversight of projects and representation to internal and external stakeholders for support on strategic planning, oversight, risks and mitigations.
• Develop and implement department SOPs.
• Lead and manage the development of new departmental process improvement and efficiency initiatives.
• 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.

Qualifications

• 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.
• Expert independent analytical and problem solving skills.
• Strong project management skills and experience managing data management teams and projects for operational and budget oversight.
• Significant line management experience including recruitment, career development and performance reviews.

Requirements

• Bachelor’s degree or higher in biomedical sciences, life sciences, computer science or related discipline — or equivalent relevant experience.
• Min of 12 years of experience in clinical data management or a related role within the pharmaceutical, biotechnology, or medical device industries.
• 6-8 years of line management experience.
• Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

Benefits

• We love knowing that someone is going to have a better life because of the work we do.