1101# Principal Data Manager /Consultant

 

 

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a  Principal Data Manager Consultant  on a contract basis. 

Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!

Responsibilities

• Lead and oversee end-to-end data management activities for assigned clinical trials, from study start-up to database lock and submission.

• Develop and review data management plans (DMPs), CRFs, edit checks, data validation specifications, and coding conventions.

• Ensure compliance with CDISC standards (SDTM/CDASH), regulatory guidelines (ICH-GCP, FDA, EMA), and company SOPs.

• Manage timelines, deliverables, and resources for data management projects, proactively identifying and resolving risks/issues.

• Serve as the primary liaison with internal teams, sponsors, CROs, and vendors for data management-related activities.

• Oversee data cleaning, query management, SAE reconciliation, coding (MedDRA, WHODrug), and database lock processes.

• Provide leadership, mentoring, and training to junior data managers, fostering knowledge sharing and best practices.

• Support regulatory submissions by ensuring high-quality datasets and documentation.

• Contribute to process improvement initiatives and adoption of new technologies in data management.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Computer Science, Statistics, or related field.

• 8+ years of clinical data management experience, including significant experience in a lead/principal role.

• Proven expertise with EDC systems (Medidata Rave, Oracle InForm, Veeva EDC, or similar).

• Strong knowledge of CDISC standards (SDTM/CDASH) and regulatory requirements (ICH-GCP, FDA, EMA).

• Experience with data cleaning, validation, coding (MedDRA, WHODrug), and database lock.

• Excellent communication, leadership, and project management skills.

• Ability to manage multiple priorities in a fast-paced environment.

 

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

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