General Summary

The temporary Clinical Data Manager acts as a lead data manager for one or more projects, applies data management experience to clinical trials, and utilizes functional knowledge of the logistics of clinical trials to ensure the quality and integrity of clinical trial data. The CDM works on multi-functional teams and supports clinical trial projects as a departmental subject matter expert (SME).

We are seeking a temporary clinical data manager who will work 40 hours a week to support ongoing study management activities. The initial assignment is for 6 months, but may be extended to meet the needs of our Team. Applicants must be eligible to live and work in the US without sponsorship.

Specific Duties and Responsibilities

•Independently lead and/or perform all data management activities within an assigned study (e.g., study startup, study conduct, study closeout, and reporting). *

•Serve as the data management SME on multidisciplinary project teams providing specific expertise on timeline development, identification of data management deliverables and resource requirements. *

•Participate in the creation, review, and maintenance of project timelines and monitor progress of data management activities. *

•Ensure Data Management documentation is filed/archived according to applicable Penumbra and regulatory requirements. *

•Interact with data management, biostatistics, clinical affairs and medical affairs teams to ensure integrity and quality of data. *

•Contribute ideas to the development of the department, identifying areas for improvement (e.g., SOPs, processes)

•Participate in audits and inspections. *

•Attend Investigator Meetings when requested to provide training on CRF data completion.

•Responsible for creation of training materials and training of the CRAs to ensure consistency of data entry at the sites. *

•Provide DM departmental training and to other teams, as needed.

•Utilize reports to track study progress and ensure timeliness and quality expectations are met.

•Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *

•Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *

•Ensure other members of the department follow the QMS, regulations, standards, and procedures. *

•Perform other work-related duties as assigned.

*Indicates an essential function of the role

Required Qualifications

Minimum education and experience

•Bachelor's degree with 5+ years of experience in a medical device, pharmaceutical, or other regulated industry; or an equivalent combination of education and experience

Preferred qualifications

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)

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
Ability to operate independently and achieve results; ability to effectively deal with

employees and business contacts and conveys a positive service-oriented attitude

Knowledge of continuous improvement, project management, change management, and

risk management

Medical device, pharmaceutical, biotech, or other regulated industry experience required
Proficiency with MS Word, Excel, and PowerPoint

Working Conditions

•General office environment

•Willingness and ability to work on site.

•May have business travel from 0% - 5% to conferences and/or other Penumbra affiliated facilities.

What We Offer

A collaborative teamwork environment where learning is constant, and performance is rewarded.
The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).

Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.

If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.

For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.