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Company name : Thermo Fisher Scientific
Location : New Jersey
Position : Data Manager – Clinical Affairs
The Data Manager role will be responsible for all data management activities regarding multiple lab developed test (LTD), companion diagnostic (CDX), and in-vitro diagnostic (IVD) clinical initiatives. The role will contribute directly to the successful performance of the initiatives through ensuring adherence to industry standards and regulatory requirements/guidances, such as Good Laboratory Practice (GLP), Good Clinical Practice (GCP), FDA, IVDR, CLIA in regard to data management.
Essential Functions for Each Initiative in Accordance with Industry and Regulatory Standards/Requirements/Guidances:
Serves as the subject matter expert for the quality and regulatory planning, set-up, acquisition, and extraction of internal and external clinical data.
Participate in internal and external meetings in support of defining data management needs for the initiatives.
Develops Data Management Plan (DMP).
Creates internal and external data transfer specifications.
Ensure clinical trial data are compatible with the clinical database and the data compilation system requirements to fulfill data integration, analysis by biostatisticians, and reporting by Clinical Affairs.
Understand internal and external laboratory testing instrument software applications for data housing and extraction purposes.
Develops and implements mechanisms to monitor the integrity of the EDC and laboratory system data.
Identifies key roles and responsibilities.
Identifies risks and mitigations to reduce the impact to the quality and timelines of the initiatives.
Independently or in collaboration with a vendor, create and manage the electronic data capture (EDC) system.
Collaborate with Clinical Affairs staff to create the Case Report Form (CRF), edit checks, queries, and user roles.
Organizes, and facilitates user acceptance testing (UAT) oversight.
Liaise between Clinical Affairs and the EDC vendor to meet existing or additional data capture needs.
Independently or in collaboration with a vendor, create and manage the laboratory information management system (LIMS), such as LDMS.
Monitors all data generated from the initiatives. Generate monitoring reports. Escalates issues in a timely manner.
Identify issues and countermeasures to reduce the impact to the quality and timelines of the initiatives.
Trains internal and external users on the appropriate use of data management tools.
Performs other tasks, as appropriate.
Works on tasks of complex scope where strategizing of situations requires a review and understanding of a variety of factors.
Developed professional expertise, applies company policies and procedures to resolve a variety of issues.
Normally receives routine guidance at during the data management planning phase of the initiatives. Routinely collaborates with Senior Manager, Clinical Affairs on data management planning, implementation, monitoring, and close-out phases of clinical initiatives. Exercises judgement with defined procedures and practices to determine appropriate action.
Contacts are primarily internal to the company with periodic external customer/vendor contact on routine matters. Builds productive and respectful internal/external working relationships.
Education and Experience:
Bachelor’s degree in life sciences or equivalent and relevant formal academic / vocational qualification.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
In some cases, an equivalency, consisting of a combination of appropriate education, training
and/or directly related experience, will be considered sufficient for an individual to meet the
requirements of the role.
Knowledge, Skills, and Abilities:
Demonstrated extensive clinical data management experience including data transfer, EDC/LIMS, database creation and management, whether working with a vendor or independently.
Demonstrated computer skills preferably spreadsheets, word processing, database, and other applicable software programs.
Ability to create quality DMPs.
Extensive knowledge industry and regulatory Standards/Requirements/Guidances, such as GCP, GLP, IVDR, applicable to data management.
Proven troubleshooting, problem solving skills with attention to detail.
Ability to adhere to internal SOPs, work instructions, and strategies.
Ability to work effectively and efficiently in a team environment and independently as needed.
Ability to maintain a high degree of confidentiality with clinical data and customer’s proprietary data.
Ability to train internal and external users on data management tools.
Ability to define and meet timelines as well as identify and mitigate schedule changes.
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