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

Penumbra

6d•$50 - $80•Onsite

About The Position

The temporary Clinical Data Manager acts as a lead data manager for one or more projects, applying data management experience to clinical trials and functional knowledge of trial logistics to ensure the quality and integrity of clinical trial data. The role works on multifunctional teams and supports clinical trial projects as a departmental subject matter expert. The position supports ongoing study activities for 20 hours per week. The initial assignment is six months and may be extended to meet team needs. Applicants must be eligible to live and work in the United States. The role requires a willingness and ability to work on site in a general office environment, with potential business travel of 0%–5% to conferences or other Penumbra-affiliated facilities.

Requirements

Bachelor's degree and at least 5 years of experience in a medical device or pharmaceutical company, CRO, or similar environment; or an equivalent combination of education and experience.
Experience working on regulatory trials in the medical device and/or pharmaceutical industry.
Experience in a medical device, pharmaceutical, biotech, or other regulated industry.
Strong experience with electronic clinical trial data capture systems, such as iMedidata Rave, InForm, eClinicalOS, or REDCap.
Thorough knowledge of effective clinical data management practices and in-depth understanding of all aspects of data management.
Knowledge of regulatory guidelines pertaining to data quality and data management.
Technical, organizational, analytical, and strong communication skills.
Ability to manage change and multiple priorities effectively.
Ability to work independently and achieve results, and to deal effectively with employees and business contacts while conveying a positive, service-oriented attitude.
Knowledge of continuous improvement, project management, change management, and risk management.
Proficiency with Microsoft Word, Excel, and PowerPoint.
Must be eligible to live and work in the United States.
Willingness and ability to work on site.
Ability to lift and move up to 25 pounds, move between buildings and floors, remain stationary and use a computer or standard office equipment for extended periods, move within the office and access file cabinets or supplies, read and prepare emails and documents, produce spreadsheets, and communicate and exchange accurate information with employees at all levels.

Nice To Haves

Master's degree with at least 3 years of clinical research experience; pharmaceutical company experience preferred.
CCDM certification is a plus.

Responsibilities

Independently lead and/or perform data management activities for assigned studies, including study startup, conduct, closeout, and reporting.
Serve as the data management subject matter expert on multidisciplinary project teams, advising on timelines, deliverables, and resource requirements.
Participate in creating, reviewing, and maintaining project timelines and monitor data management progress.
Oversee Data Management CROs and other vendors to ensure compliance with protocols, standards, Good Clinical Practices, regulatory guidelines, SOPs, and other applicable requirements.
Ensure data management documentation is filed and archived according to Penumbra and regulatory requirements.
Collaborate with data management, biostatistics, Clinical Affairs, and Medical Affairs to ensure data integrity and quality.
Contribute to departmental development and identify opportunities to improve SOPs and processes.
Participate in audits and inspections.
Attend Investigator Meetings when requested and provide training on CRF data completion.
Create training materials and train CRAs to promote consistent data entry at study sites.
Provide data management departmental training and training to other teams as needed.
Use reports to track study progress and ensure timeliness and quality expectations are met.
Adhere to the Company's Quality Management System and applicable domestic and global quality regulations, standards, and procedures.
Follow applicable security, privacy, and compliance principles, regulations, standards, and procedures.
Ensure other department members follow the QMS and applicable regulations, standards, and procedures.
Perform other work-related duties as assigned.