Clinical Data Manager

Watertown, MA

Clinical Data Manager 2032279
Location: Watertown, MA (Hybrid/Remote)
Science: Small Molecule
Therapeutic Area: Oncology
Job Overview: This role will independently manage and prioritize clinical study data procedures while providing expert guidance across international teams, effectively maintaining oversight as the data management subject matter expert.
Primary Job Responsibilities:

  • Serve as the key data management expert on clinical project teams, guiding timelines and deliverables from study setup to database lock, with continuous monitoring of data management activities.
  • Oversee the development and testing of clinical databases and data cleaning procedures, utilizing Medidata Rave/Veeva, and enforce data integrity through comprehensive documentation and quality control.
  • Manage collaborations with CROs and third-party vendors, oversee data analysis and reconciliation, and communicate project updates and metrics to enhance decision-making and reporting accuracy.
Primary Job Requirements:
  • Bachelor’s Degree in Life sciences, including a min of 8 years in CDM, leading critical oncology or immunology projects from startup to database lock, adept at handling data for regulatory submissions, and proficient in Veeva EDC system management with a solid scientific educational background.
  • Skilled in using a variety of data management tools and systems (e.g., IRT, ePRO, Veeva CDMS, Oracle), focusing on data integrity and effective communication of data standards and practices.
  • Expert in GCDMP, CDISC standards, regulatory compliance (21 CFR Part 11, GDPR), and proficient in MedDRA and WHO-Drug coding, ensuring adherence to ICH GCP and industry standards.

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.

 

 

 

 

 

 

 

 

 

 

 

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@apexsystems.com or 844-463-6178.

Employee Type:
Contract

Location:
Watertown, MA

Job Type:
Strata: Clin/Reg

Date Posted:
June 6, 2024

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