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Sr. Clinical Trial Manager

🕒 20 days ago
Clinical Trial ManagementOncology StudiesCRO ManagementRegulatory Compliance
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📜 Description

  • Support day-to-day activities within one or more clinical trials, including 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 and escalate to appropriate stakeholders as needed.
  • Help ensure inspection readiness, TMF quality, and adherence to protocol and regulatory requirements.
  • Proactively identify operational challenges and propose mitigation plans to keep study execution on track.

🛠️ 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.

✨ 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
Full job description

Frontier Medicines is seeking two Sr. 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 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.

● 5-7 years of Clinical Trial Manager/SCTM 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 $125,000 - $170,000. 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.

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