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.
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Discover Impactful Work:
As part of the Clinical Data Management (CDM) team, the Sr. Clinical Data Manager is responsible for the day-to-day registry data activities, planning, execution, and delivery of data for multiple observational registries in a variety of therapeutic areas. The Sr. Clinical Data Manager must be able to efficiently organize workload of several simultaneous deliverables to ensure timely and accurate delivery and is expected to collaborate with personnel within the CDM team as well as across other functional areas.
A day in the Life:
• Collaborate with respective registry subscribers, functional areas, and stakeholders to develop effective CDM project plans to include scope, goals, deliverables, risks, issues, and milestone timing.
• Assign tasks and responsibilities within CDM to team members, in a manner that optimizes team capability, delivers timely and accurate results, and supports the needs of the business.
• Ensure that the assigned team executes CDM functions in accordance with CorEvitas Standard Operating Procedures (SOPs), if applicable.
• Provide guidance to less-experienced Clinical Data Managers.
• Clearly communicate expectations to team members and stakeholders.
• Resolve issues and solve problems.
• Serve as Data Management Lead on selected observational registries.
• Create registry specific Data Management Plans (DMPs) and Data Completion Guidelines.
• Provide input with preparation of edit check specifications, as applicable.
• Effectively manage operational registry scope by ensuring any changes to scope are documented and approved through proper change management processes.
• Review data to ensure timeliness, completeness, and quality. Issuing and resolving queries as appropriate; raising awareness and risks.
• Assist with the creation of test data for entry screens and edit checks. Perform UAT for new registry builds as well as for mid-study updates (MSUs), as needed.
• Attend and/or participate in registry meetings as well and any company-wide meetings.
• Collaborate with respective registry leads and/or stakeholders to provide registry data updates, cleanliness, risks and mitigation plans, and metrics.
• Participate in and/or contribute to any internal and/or external Regulatory audits and/or inspections, as applicable.
Keys to Success:
Education
• Bachelor’s degree preferred, High school diploma required
Experience
• 6 or more years’ experience leading Data Management projects.
• Experience with REDCap Cloud, Zelta (IBM Clinical Development), RAVE or equivalent EDC platform.
Knowledge, Skills, Abilities
• Proven ability to lead data management activities for large, multiple projects simultaneously.
• Ability to maintain confidentiality of data and information during interactions with staff at all levels.
• Excellent communication skills to support effective interactions with Subscribers and internal colleagues.
• Advanced proficiency in Microsoft Excel or equivalent software.
• Prior experience in the pharmaceutical, biotechnology, medical device/diagnostic, or clinical trial industries.
• Extreme attention to detail and ability to multitask with strong prioritization, planning, and organization skills
• Dedication to process improvement while producing high quality work within required timeframes.
• 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.
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