Sr Manager, CDM
- Cambridge, Massachusetts
- Datenmanagement und Biostatistik
Senior Manager, Clinical Data Management
Summary: Senior Manager, Clinical Data Management is responsible for leading a CDM team/workstream through sharing strategic responsibility for the CDM department, or full strategic responsibility for a CDM clinical program. Senior Manager, Clinical Data Management performs and delegates tasks from study start-up to close-out according to the study protocols, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements. Effectively manages vendors. Mentors junior personnel. Ensures consistent planning and execution within and across assigned CDM studies, anticipates internal business challenges and successfully drives towards the best solution for the organization.
- Lead a CDM team / workstream through navigating complex problems and driving solutions based on best practices.
- Oversee all 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.
- Establish strong relationships with data management vendors to enable optimal outcomes.
Knowledge, skills, and abilities required:
- 7+ years of experience as a CDM in Pharma, Biotech, and/or CRO
- Has in-depth and breadth of expertise in CDM function and considerable experience working cross-functionally to achieve results.
- Able to lead CDM team/workstream through navigating complex problems where analysis of situations requires a deep understanding of the company and best practices.
- Demonstrates ability to anticipate internal business challenges and successfully drives towards the best solution for the organization.
- Able to 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.
- Able to perform long Range Planning, typically for 6-12 months
- Must be able to work in a highly matrixed fast-paced environment with changing priorities and deadlines.
- Highly organized and detail oriented
- Strong delegation skills
- Strong project management and meeting facilitation skills
- Able to manage time effectively and prioritize
- GCP knowledge
- Therapeutic Area knowledge
- Demonstrated experience in writing professional correspondence and clinical study documentation
- Strong EDC skills in various EDC systems, e.g., Medidata Rave and IBM Health
- Strong understanding of clinical trial data
- Strong communication skills
Sthree US is acting as an Employment Business in relation to this vacancy.