Clinical Data Manager (Temporary Position, 20 hours/week)

Your Remote US Home Officefull time

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Remote

mid

H1B: no

Penumbrainc The temporary Clinical Data Manager leads data management activities for clinical trials, ensuring data quality and integrity. This role acts as a subject matter expert on multidisciplinary teams and oversees vendor compliance with protocols and regulations.

Responsibilities

Independently lead and/or perform all data management activities within an assigned study
Serve as the data management SME on multidisciplinary project teams
Participate in the creation, review, and maintenance of project timelines and monitor progress
Provide oversight for Data Management CRO and other vendors to ensure compliance
Ensure Data Management documentation is filed/archived according to requirements
Interact with data management, biostatistics, Clinical Affairs and Medical Affairs teams
Participate in audits and inspections
Attend Investigator Meetings to provide training on CRF data completion
Create training materials and train CRAs to ensure consistency of data entry
Provide DM departmental training and to other teams as needed
Utilize reports to track study progress and ensure timeliness and quality
Adhere to the Company’s QMS and relevant regulations, standards, and procedures

Qualification

Minimum education and experiencePosition requires technical

Required

Minimum education and experience
•Bachelor's degree with 5+ years in a medical device, pharmaceutical company, or similar environment (e.g., CRO); or an equivalent combination of education and experience

Preferred

•Master’s degree with 3+ years of clinical research, pharmaceutical company preferred
•Thorough knowledge of effective clinical data management practices; CCDM certified professional a plus
•Must have strong experience with systems used for electronic capture of clinical trial data (e.g., iMedidata Rave, InForm, eClinicalOS, RedCap)
•This position must have experience working on regulatory trials within the medical device and/or pharmaceutical industry
•Position requires technical, organizational, analytical, and strong communication skills
•Knowledge of regulatory guidelines pertaining to data quality and data management
•Proven experience and in-depth understanding of all aspects of Data Management
•Ability to effectively manage change and multiple priorities