Part-Time Clinical Data Manager (6-Month Temp)

Resumonk; United States; Remote; USD 69,000 - 110,000; Part time

Benefits offered by this job

Medical, dental, vision

401(k) with employer match

Paid holidays and vacation

Job summary

Penumbra, Inc. is seeking a temporary Clinical Data Manager to lead data management for one or more clinical projects. The role supports trials, ensures data quality and integrity, and acts as a departmental SME on data management. The assignment is 20 hours per week for an initial 6-month period with US work eligibility required.

You will collaborate with cross-functional teams, supervise vendors, and contribute to process improvements while adhering to GCP and QMS standards.

Qualifications

• Bachelor's degree with 5+ years in a medical device, pharmaceutical company, or similar environment.
• Master's degree with 3+ years of clinical research preferred.
• Thorough knowledge of effective clinical data management practices; CCDM a plus.
• Experience with electronic data capture systems such as iMedidata Rave, InForm, eClinicalOS, REDCap.

Responsibilities

• Independently lead and/or perform all data management activities within an assigned study (startup, conduct, closeout, reporting).
• Serve as the data management SME on multidisciplinary project teams providing timeline development and deliverables.
• Participate in creating, reviewing, maintaining project timelines and monitoring progress.
• Provide oversight for Data Management CROs and vendors to ensure compliance with protocol and regulations.
• Ensure DM documentation is filed/archived according to QMS and regulatory requirements.
• Interact with data management, biostatistics, Clinical Affairs and Medical Affairs teams to ensure data integrity.
• Contribute ideas to department development, SOPs, and processes.
• Participate in audits and inspections.
• Attend Investigator Meetings to provide CRF data completion training.
• Create training materials and train CRAs to ensure data entry consistency at sites.
• Provide DM departmental training to other teams as needed.
• Utilize reports to track study progress and ensure timeliness and data quality.
• Adhere to the company's QMS and relevant regulations and standards.
• Understand privacy and compliance principles applicable to the company.
• Ensure department members follow QMS and standards.
• Perform other work-related duties as assigned.

Skills

Data management

GCP knowledge

Project coordination

Regulatory compliance

MS Office

Education

Bachelor's degree

Master's degree

Tools

iMedidata Rave

InForm

eClinicalOS

REDCap

Job description

Penumbra, Inc. is seeking a temporary Clinical Data Manager to lead data management for one or more clinical projects. The role supports trials, ensures data quality and integrity, and acts as a departmental SME on data management. The assignment is 20 hours per week for an initial 6-month period with US work eligibility required.

You will collaborate with cross-functional teams, supervise vendors, and contribute to process improvements while adhering to GCP and QMS standards.