Associate Director, Clinical Data Management

Proclinical, in support of our client, are seeking an individual to fill the role of Associate Director, Clinical Data Management, based in Cambridge, MA. The successful candidate is responsible for leading a CDM team/workstream, and will share strategic responsibility for the CDM department, or full strategic responsibility for a CDM clinical program.

Responsibilities

• Lead a CDM team/workstream through navigating complex problems and driving solutions based on best practices.
• Oversee day-to-day data management activities, timelines and deliverables for assigned projects and team members.
• Provide technical and business expertise in support of data management deliverables.
• Ensure compliance with SOPs and work instructions.
• Facilitate effective planning and execution of all the data management tasks for direct reports.
• Ensure timeliness and quality of data deliverables in collaboration with CDM team members and cross-functional colleagues
• Enable use of consistent data management approaches across Therapeutic Areas through adoption of standards and best practices.
• Develop assigned individual contributors to advance their data management skillset through training, mentorship, and coaching.
• Enable high performance, mentorship, and career development for the assigned team members.
• Perform resource forecasting and allocation for direct reports.
• Participate in initiatives around process development, standardization, and technology.
• May serve as CDM study lead or program lead.
• May work with database programmers to develop EDC databases, edit checks and reports.
• Provide oversight of tasks performed by third-party vendors and data management CROs.
• Lead CDM team/workstream through navigating complex problems where analysis of situations requires a deep understanding of the company and best practices.
• Share strategic responsibility for an area of major corporate impact, such as department, or full strategic responsibility for an area of limited corporate impact, such as clinical program.
• Establish strong relationships with data management vendors to enable optimal outcomes.

Skills And Qualifications

• BA, preferably in health science or related field.
• Expertise in CDM function and considerable experience working cross-functionally to achieve results.
• Demonstrate ability to anticipate internal business challenges and successfully drives towards the best solution for the organization.
• Able to perform long Range Planning, typically for 6-12 months
• Knowledge of GCPs and relevant therapeutic area.
• Demonstrated experience in writing professional correspondence and clinical study documentation
• Strong EDC skills in various EDC systems.
• Strong understanding of clinical trial data.
• Strong written, verbal, and interpersonal communication skills.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Brandon Zheng at (+1) 646-851-0869 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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