Clinical Trial Manager
It takes a team to reach the summit.
Join us to build a future in which each patient has access to the right physicians, the right tests, and the right therapeutics to treat their individual tumor.
Elevation Oncology, a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, has an opening for an experienced Clinical Trial Manager.
Reporting to Senior Director Clinical Operations, you will be responsible for actively managing all aspects of clinical trials, establishing effective working relationships with clinical trial sites and clinical vendors to ensure timely and accurate reporting of trial data.
- Ensure clinical sites are executing research according to the clinical protocol, local regulations, Code of Federal Regulations (CFR), ICH and Good Clinical Practice (GCP) guidelines
- Management of site activities including monitoring recruitment, enrollment, data collection and data entry.
- Participate in vendor management and oversight
- Escalate identified risks to the Director of Clinical Operations or appropriate stakeholder and follow through to resolution
- Contribute to the development of study training and ancillary project management materials including databases and trackers
- Review site level clinical documents (ICFs, IRB approvals, etc.) and clinical monitoring reports; review and maintain study level clinical plans (including, but not limited to, site monitoring plan, deviation plan, data management plan)
- Manage the Trial Master File (TMF) and perform ongoing quality reviews
- Liaise with the CRO and clinical sites to ensure clinical data is entered appropriately
- Support preparation of data and other information for internal and external presentations; participate in internal and external team meetings to share updates on progress of activities
- Support Health Authority Inspections and Inspection preparedness, including participating in co-monitoring activities which may involve travel
- Additional responsibilities as assigned
Required Skills and Qualifications
- Bachelor’s degree in related field required. Minimum of five (5) years prior clinical trial experience including full trail life-cycle (site selection, initiation, data gathering, data lock and study close-out. Majority of this experience should be with Oncology trials.
- Excellent written and verbal communications skills; able to effectively interact with people at all organizational levels and
- Good interpersonal skills and able to establish positive and professional relationships.
- Strong understanding of regulatory requirements and ensures all trials comply with established protocols.
- Proficient at using electronic data capture (EDCs), trial master file (TMFs) and interactive response technology (IRTs)
- Experience with global, early phase clinical trials (phase I/II) preferred
- Availability to travel to Clinical Trial sites is required with potential travel 10% of time and in the US.
- Must be located within and authorized to work in the United States today and in the future.
Life at Elevation Oncology
Our values lay the foundation for the road ahead:
INTEGRITY: We’re committed to identifying and targeting the genomic targets that can make the most meaningful difference to a patient, no matter how rare. Each tumor is unique, and every patient deserves access to a drug that is made with their tumor in mind, whether made by Elevation Oncology or an industry peer.
COMMUNITY: We celebrate the unity in our shared mission and the diversity of our strengths both as individuals in a team, and as a company in a vibrant precision medicine community. We actively seek and nurture effective collaborations and strive to be a trustworthy corporate citizen.
ADVOCACY: We advocate for the widespread adoption of genomic testing and a cooperative effort supporting patient awareness and education. We believe that only as a unified industry can we can best provide our patients with a clear path forward.
If you share our beliefs and are interested in helping to further our mission, send your resume or CV to firstname.lastname@example.org and tell us how you can help. We look forward to meeting you!
Elevation Oncology is an equal opportunity employer and encourages applications from all individuals.