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 Cor Evitas 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.

Brief Description:

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.

Requirements:

• Excellent verbal and written communication.
• Demonstrated knowledge of clinical data management process in a biotechnology or pharmaceutical setting.
• Good project management, organizational, and time management skills and the ability to juggle multiple projects at once.
• Strict attention to detail and quality with the ability to think critically and possess strong problem-solving skills.
• Knowledge of International Council for Harmonisation (ICH) and Good Clinical Practice (GCP) guidelines.
• Understanding of clinical trial process (design and conduct) across Phases I-IV studies. Phase IV and/or Real-World Evidence (RWE) experience a plus.
• Team-oriented mindset with the initiative to complete goals.
• Consistent professional demeanor especially during times of high stress and tight timelines.

Supervisory Responsibilities:

• May have up to four direct reports depending on registry need and workload.

Specific Job Duties:

• 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 the assigned team executes CDM functions in accordance with Cor Evitas Standard Operating Procedures (SOPs), as applicable.
• Provide guidance to less-experienced Clinical Data Managers.
• Serve as Data Management Lead on selected observational registries
• Clearly communicate expectations to team members and stakeholders. Resolve issues and solve problems.
• Review and/or oversee the review of 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 cross-departmentally and/or with 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.

Education and Experience:

• Bachelor’s degree and/or minimum 6 years of experience working in pharmaceutical or biotech industry.
• Minimum of 4 years’ data management experience or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills, and abilities to perform the job.
• To be effective in this role, you must have comprehensive knowledge of all applicable regulations, including CFR, GCP, and ICH Guidelines.

Travel:

• May be up to 5% per year.

Other Duties:

• This job description does not provide a comprehensive listing of duties, responsibilities, or activities that are required of the employee for this position. Duties, responsibilities, and activities may change at any time with or without notice.

• 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. #Start Your Story with Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com
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.
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