Sr. / Clinical Data Manager 1370414

Location: Waltham, MA (Hybrid)
Science/ Focus: Immuno-Oncology
Therapeutic Area: Early stage I-O assets

Job Overview: Responsible for leading two early phase studies to include assisting with the design and implementation of clinical data management systems with vendors. Reporting into the AD, Clinical Data Manager, you will be the 4th member of the team and will collaborate cross functionally.

Responsibilities:

• Provide clinical study level data management oversight of outsourced clinical trials including: project management, vendor management, coordination of internal reviews, and approval of deliverables.
• Oversee database design and production, ensuring that CROs, vendors and internal staff meet all deliverables.
• Assist as author/reviewer for eCRFs, eCCGs, and Data Management Plans.
• Review data analysis listings and report on performance and quality; review clinical data within studies and across programs for trend analysis.
• Assist as needed with clinical documents such as clinical protocols, investigator brochure updates, annual reports and status updates.
• Collaborate with Clinical Operations to ensure the data management component of the eTMF is maintained throughout the trial.

Qualifications:

• Bachelor’s degree in a biomedical, life science or related field of study
• 3-5 years of clinical data management experience including 2+ years in oncology trials
• Ability to collaborate effectively with the cross-functional study team and external partners using collaborative negotiation skills.
• Working knowledge and experience with FDA regulations and familiarity with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide coding dictionaries such as MedDRA.

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.

cmacdonald@stratacuity.com

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.