Thermo Fisher Scientific | Associate Director of ...

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - To enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. As part of our clinical research portfolio, our CorEvitas evidence-based solutions specialize in generating data intelligence and clinical insights needed to bring safe and effective treatments to market. Your objectivity and dedication to patient safety will improve health outcomes that people and communities depend on - now and in the future. Location/Division Specific Information #CorEvitas Discover Impactful Work: As part of the Clinical Data Management (CDM) team, the Associate Director of Clinical Data Management is responsible for managing the data manager to ensure staffing and operational aspects are in line with the company's strategic business objectives. This role will also develop, improve, and/or refine data management processes and supporting documentation (SOPs, Work Instructions, etc.) that govern the lifecycle of data collection, storage, and reporting. A day in the Life: • The AD CDM must be able to efficiently organize the workload of several team members across all registry studies to ensure deliverables are met in a timely and accurate manner. Must have a strong aptitude for resource management, budget forecasting, process writing, and mentoring. This position is a direct line management role and experience managing a team of three or more is preferred. Strong expertise in EDC systems across a variety of platforms is required as some hands-on data management will be expected. Must also possess a working knowledge of clinical research and relevant regulation. ESSENTIAL FUNCTIONS • Supervise / lead data managers and activities supporting CorEvitas' clinical registries from start-up through each revision cycle. • Compile and manage CDM documentation (e.g., data management plan, completion guidelines, etc.) to ensure master files are up-to-date and audit ready. • Participate in design and/or review of new/revised forms. • Oversee new EDC builds, mid-study updates, and/or fixes. • Represent CDM in meetings with internal cross-functional teams. • Collaborate with cross-functional individuals from Registry Operations, Medical Affairs, Quality/Regulatory, Project Management, Biostatistics, Epidemiology in support of registry deliverables. • Contribute to project budget, resource planning, tracking CDM metrics/milestones, and ensuring data quality. • Manage direct staff's training compliance, performance evaluations, goal setting, and career development. • Collaborate with Director CDM on department growth, goals, processes, and support several department initiatives. • Participate in and/or contribute to Subscriber and/or Regulatory audits and/or inspections. • Participate/attend Subscriber and/or functional team meetings, as required. • Perform other duties as required by the Department. Keys to Success: Education • Bachelor's degree preferred, High school diploma required. Experience • 7 or more years' experience within Clinical Data Management in biopharmaceutical/biotech, or CRO setting. • 3 or more years' in a supervisory or leadership role. Knowledge, Skills, Abilities • Proven ability in core DM activities, processes, and documentation. • Excellent communication skills to support effective interactions. • Extreme attention to detail and ability to multitask with strong prioritization, planning, and organization skills. • Advanced proficiency in Microsoft Office Suite • Prior experience in the pharmaceutical, biotechnology, medical device/diagnostic, or clinical trial industries. • Strong knowledge of FDA Title 21 CFR Part 11. • Dedication to process improvement while producing high quality work within required timelines. • Strong English communication and writing skills. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Apply today! Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. Accessibility/Disability Access Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. 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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Created: 2024-11-28