Clinical Data Specialist III

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific youll 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.

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 CorEvitas 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:

• Bachelors 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 100000 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.
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