Description
Frontier Medicines is seeking two Clinical Trial Managers to support the day-to-day execution of our oncology clinical trials as they advance through clinical development. Working under the guidance of our Director/Sr. Director, Clinical Operations, you will serve as a key operational contact for our CROs and trial sites, helping drive feasibility assessments, site selection, start-up, maintenance, and close-out.This is a great opportunity for someone who wants hands-on ownership of trial execution at a growing, clinical-stage biotech, with direct exposure to program strategy and cross-functional leadership.
This is a hybrid role based in our Boston, MA office, with an expectation of 2-3 days per week onsite, plus periodic travel to trial sites and CRO/vendor meetings as needed.
Requirements
What will you be doing?
● Support day-to-day activities within one or more clinical trials, including country/site feasibility assessments, site selection, start-up, maintenance, and close-out.● Serve as a key operational point of contact for CROs and trial sites, identifying and escalating potential issues as needed.● Assist with oversight of CRO and vendor set-up, liaising with CROs to ensure timely study initiation.● Review site-level regulatory documents (e.g., Informed Consent Forms, essential documents) and escalate to appropriate stakeholders as needed.● Help ensure inspection readiness, TMF quality, and adherence to protocol and regulatory requirements.● Proactively identify potential operational challenges and, in partnership with senior team members, propose mitigation plans to keep study execution on track.● Assist with review of protocols, master template informed consent forms, case report forms, and other clinical study documents as needed.● Monitor study performance metrics, timelines, and deliverables, and review CRO trip reports for trends and quality issues.● Track study budgets and vendor invoices/change orders in partnership with Clinical Operations and Finance, flagging discrepancies as needed.
● Help maintain timely and accurate study registration and updates on ClinicalTrials.gov and other applicable registries.● Coordinate Clinical Trial Team meetings and drive action item follow-up.● Maintain clinical operations trackers, databases, and document repositories.● Provide regular study updates to internal stakeholders and support enrollment, database lock, and study closeout activities.
Traits we believe make a strong candidate:
● Bachelor's degree in a scientific, healthcare, or related field, or an RN, required.● 3-4 years of Clinical Trial Manager or Clinical Project Management experience, ideally supporting oncology clinical trials.● Experience supporting oncology studies strongly preferred.● Vendor and CRO management experience.● Strong working knowledge of ICH-GCP guidelines and clinical trial regulations.● Excellent organizational, problem-solving, and time management skills, with strong attention to detail.● Strong written and verbal communication skills with a collaborative, team-oriented approach.● Comfortable in a fast-paced, dynamic environment; a proactive, roll-up-your-sleeves mindset.● Legally authorized to work in the United States.
Benefits
- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan (401k, IRA)
- Life Insurance (Basic, Voluntary & AD&D)
- Paid Time Off (Vacation, Sick & Public Holidays)
- Family Leave (Maternity, Paternity)
- Short Term & Long Term Disability
- Training & Development
- Free Food & Snacks
- Wellness Resources
- Stock Option Plan
At Frontier, we strive to build a diverse and equitable workplace. The salary range for this role is $120,000 - $150,000 Compensation for the role will depend on a number of factors, including candidates' qualifications, skills, competencies and experience. Frontier offers a competitive total rewards package which includes healthcare coverage, 401k and a broad range of other benefits. This compensation and benefits information is based on Frontier's knowledge as of the date of publication, and may be modified in the future.
