Principal Clinical Data Manager

Watertown, MA

Principal Clinical Data Manager 1135188

Job Scope & Purpose:

Our long-term client offers a robust pipeline, substantial funding and stability, and is on the edge of bringing their first compound through approval!  As their pipeline in viral infections and liver diseases grows, so does their team; they seek an experienced Principal Clinical Data Manager to assume responsibilities for the data management activities and deliverables of clinical trials (Phase I to Phase III). Externally, the Principal Data Manager effectively manages Data Management CROs overseeing all outsourced data management activities and ensuring quality and timeliness of deliverables.  Internally, the Principal Data Manager collaborates with cross functional team members, including but not limited to Clinical Operations, Statistical Programming, Clinical Pharmacology, Medical Writing and Medical Directors to develop and meet project deliverables and timelines. The Principle Data Manager needs to be able to function in a fast paced and dynamic environment.

Primary Job Responsibilities:

  • Provide oversight to Clinical Data Management CROs/vendors for assigned trials to ensure data quality, integrity and timelines.
  • Represents Data Management function within internal study teams and as the sponsor representative for Data Management within vendor study teams.
  • Oversee development and review of Case Report Forms (eCRFs), Data Management Plan, Validation Specifications, Data transfer Specifications, etc.
  • Participate in sponsor UAT of production EDC database release.
  • Supervise reconciliation activities for data from external data vendors.
  • Ensure clinical data within EDC is of high quality to support statistical review, interim review, and or final database lock.
  • Facilitate creating data management reports and metrics.
  • Ensure deliverables/timelines are met (DSMB, IA and database lock, etc.)
  • Review specifications for data collection technology such as eCOA, Integrated Response Technology, etc. required to support CSR study data.

Primary Job Requirements:

  • Bachelor’s degree required
  • About 7-10 years relevant clinical data management experiences in pharmaceutical/biotechnology industry
  • Experience working in an outsourced data management model
  • Proficient in multiple EDC platforms (RAVE, Inform, OCRDC, etc) and related processes (database build, mid-study database update and database lock, etc)
  • Familiar with CDASH/SDTM CDISC standards
  • Contributed to oversight of the data collection and cleaning of third-party data, ie, Lab, eDiaries, IRT, etc
  • Conversant on advanced medical terminology
  • Good understanding of coding (MedDRA, WHO drug dictionaries)
  • Able to work and communicate effectively in a small company environment

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

jprice@stratacuity.com

 

Code: ClinOps

 

 

 

 

 

 

 

 

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.