Principal clinical data manager

Randstad Technologies; Cambridge (MA); Remote; USD 60,000 - 80,000; Full time

Job summary

Randstad Technologies is seeking a Principal Clinical Data Manager for a 12-month remote contract. This role involves owning the entire data lifecycle in a lean biotech environment, from eCRF design to database lock. The ideal candidate has extensive experience in Clinical Data Management and thrives in autonomous settings, driving technical deliverables without significant oversight.

Benefits

Comprehensive benefits package including medical, dental, and vision

401K plan

Short-term disability

Life insurance offerings

Qualifications

• Minimum of 10 years' experience in Clinical Data Management in biotech or pharma.
• Experience managing all DM deliverables from study start-up to database lock.
• Proficiency in multiple EDC platforms required.

Responsibilities

• Lead the development and maintenance of the eCRF in IBM EDC system.
• Manage and update all DM documents, including guidelines and Data Management Plan.
• Perform data review for critical data points and resolve complex discrepancies.

Skills

CRFs

CDASH

Clinical Data Management

EDC (Electronic Data Capture)

Education

Bachelors

Job description

Job Summary

Principal Clinical Data Manager

100% Remote (EST Hours)

12-Month Contract

This is a technical data manager who thrives on building studies from the ground up and owning the entire data lifecycle. As the independent leader of this function, you will have hands-on ownership of the full DM lifecycle from eCRF design, UAT, and DM Plan development through final database lock. This is a lean biotech environment, ideal for a professional who can execute all technical deliverables without established SOPs or significant oversight.

location: Telecommute

job type: Contract

salary: $70 - 80 per hour

work hours: 9 to 5

education: Bachelors

Responsibilities

ROLE

• Lead the hands-on development and maintenance of the eCRF in our IBM EDC system. This includes personally designing mockups, programming edit checks, and executing all UAT for the initial build and any mid-study updates.
• Author, own, and update all key DM documents, including eCRF guidelines and the Data Management Plan (DMP).
• Personally perform data review for critical data points and serve as the expert for the DM review team, resolving complex data discrepancies yourself.
• Actively manage and reconcile external vendor data feeds by writing and reviewing data transfer specifications and performing the reconciliation.
• Drive all technical database lock activities, from final data cleaning and query resolution to executing the final lock procedures in the system.
  
  

Qualifications

REQUIRED QUALIFICATIONS

• A minimum of 10 years of hands-on experience in Clinical Data Management within the biotech or pharmaceutical industry.
• Deep, end-to-end project experience with the proven ability to single-handedly manage all DM deliverables from study start-up and eCRF design through final database lock.
• Proven success thriving in a fast-paced, lean environment (small pharma/biotech strongly preferred) where you have previously worked with a high degree of autonomy.
• Demonstrable experience creating structure, including building Data Management Plans, eCRF guidelines, or other procedural documents from scratch.
• Proficiency across multiple EDC platforms is required (Rave, IBM, etc)
  
  

skills: CRFs, CDASH, Clinical Data Management, EDC (Electronic Data Capture)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [e-mail].

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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