LumaBio Partners
Senior Manager, Clinical Data Management
This range is provided by LumaBio Partners. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $180.00/hr - $200.00/hr
Direct message the job poster from LumaBio Partners
We are working with a late-stage oncology biotechnology company advancing innovative therapies to improve outcomes for patients with cancer. With multiple Phase 3 clinical programs underway, they are expanding our clinical operations team and seeking an experienced Clinical Data Manager to play a key role in ensuring high-quality data delivery across our pivotal studies.
Key Responsibilities
Serve as the primary data management lead for assigned oncology studies, including complex, multi-center Phase 3 trials.
Develop and maintain data management plans (DMP), data validation specifications, and CRF completion guidelines.
Lead database design, edit check development, and user acceptance testing (UAT) in collaboration with EDC vendors (e.g., Medidata Rave, Oracle InForm, or Veeva CDMS).
Oversee external data transfers and integration (e.g., central lab, imaging, biomarker, PK, PRO/ePRO, IVRS).
Manage and reconcile queries, coding (MedDRA, WHODrug), and serious adverse event (SAE) reconciliation.
Ensure adherence to timelines for database locks and interim data deliveries.
Collaborate closely with Clinical Operations, Biostatistics, Medical Monitoring, and Programming teams.
Participate in data review meetings and data review listings generation.
Contribute to process improvement initiatives and SOP development within Clinical Data Management.
Support regulatory submissions and audits, providing traceable, inspection-ready documentation.
You will be part of a passionate and science-driven team dedicated to delivering transformative cancer therapies. They offer a dynamic, collaborative culture, competitive compensation, and opportunities to grow with a company on the path to registration and commercialization.
Referrals increase your chances of interviewing at LumaBio Partners by 2x
Waltham, MA $140,000.00-$155,000.00 1 month ago
#J-18808-Ljbffr
Base pay range $180.00/hr - $200.00/hr
Direct message the job poster from LumaBio Partners
We are working with a late-stage oncology biotechnology company advancing innovative therapies to improve outcomes for patients with cancer. With multiple Phase 3 clinical programs underway, they are expanding our clinical operations team and seeking an experienced Clinical Data Manager to play a key role in ensuring high-quality data delivery across our pivotal studies.
Key Responsibilities
Serve as the primary data management lead for assigned oncology studies, including complex, multi-center Phase 3 trials.
Develop and maintain data management plans (DMP), data validation specifications, and CRF completion guidelines.
Lead database design, edit check development, and user acceptance testing (UAT) in collaboration with EDC vendors (e.g., Medidata Rave, Oracle InForm, or Veeva CDMS).
Oversee external data transfers and integration (e.g., central lab, imaging, biomarker, PK, PRO/ePRO, IVRS).
Manage and reconcile queries, coding (MedDRA, WHODrug), and serious adverse event (SAE) reconciliation.
Ensure adherence to timelines for database locks and interim data deliveries.
Collaborate closely with Clinical Operations, Biostatistics, Medical Monitoring, and Programming teams.
Participate in data review meetings and data review listings generation.
Contribute to process improvement initiatives and SOP development within Clinical Data Management.
Support regulatory submissions and audits, providing traceable, inspection-ready documentation.
You will be part of a passionate and science-driven team dedicated to delivering transformative cancer therapies. They offer a dynamic, collaborative culture, competitive compensation, and opportunities to grow with a company on the path to registration and commercialization.
Referrals increase your chances of interviewing at LumaBio Partners by 2x
Waltham, MA $140,000.00-$155,000.00 1 month ago
#J-18808-Ljbffr