Skip to content

Job Openings

Senior/Principal Data Manager

Remote, IL 00000

Posted: 01/08/2024 Employment Type: Direct Hire/Perm Job Category: Data Sciences Job Number: 589749 Is job remote?: Yes Country: United States

Job Description

Job Purpose & Responsibilities 
Job Purpose: Principal Data Manager performs day-to day Data Management activities. Works closely with DM manager, senior manager, or associate director to ensure end to end data management coverage of all assigned studies and consistency across study program. 
This position requires the following critical abilities:  •    Capable of handling all DM tasks including (but not limited to) protocol review, eCRF and edit check specifications, UAT, DMP, eCRF completion guidelines, SAE and external data reconciliations, database lock activities.
•    Capable of mentoring data managers and data coordinators as needed.
•    Strong interpersonal skills as well as outstanding verbal and written communication skills.
Job Responsibilities:
Responsibilities include and are not limited to the following:
•    Review protocol and attend protocol review meetings or provide feedback, as needed.  
•    Develop eCRF specification according to the protocol.
•    Develop or lead the review of edit check specification, as well as perform/coordinate UAT.
•    Author or review eCRF completion guidelines.
•    Develop or lead the review of a Data Management Plan (DMP).
•    Provide study metrics and status reports to internal and/or client teams.
•    Perform or lead data cleaning activities.
•    Perform or lead SAE reconciliation activities.
•    Perform or lead external data reconciliation activities.
•    Perform or lead database lock activities.
•    Generate study timelines.
•    Ensure approved study documents are maintained and properly stored in trial master file.
•    Mentor junior team member as needed.
    
Qualifications
(a)    Academic / Major:  BS/BA
 
(b)    Professional Skills:  
•    Advanced knowledge of Clinical Data Management process and procedure.
•    Proficient knowledge of industry standards and regulatory requirements.
•    Proficient knowledge of Medidata RAVE, Oracle InForm, and/or IBM Clinical Development
•    Comprehension of the principles of quality, safety, risk management and compliance (ICH and GCP).
(c)    Working Experience: 5 or more years' experience in clinical data management (Senior-level) or 7 or more years’ experience (Principal level)
 
(d)    Language ability: Fluent in English.

(e)    Computer Literacy: Microsoft Office Suite, MS Teams, Adobe, Medidata Rave, Oracle InForm, and/or IBM Clinical Development.

(f)    Other abilities such as Communication skills: Excellent verbal and written communication and problem-solving skills.
 
 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.