Sr. Clinical Trial Manager

Xtalks; Boston (MA); Hybride; USD 125 000 - 170 000; Plein temps

Avantages offerts par ce poste

Health plan

401k/IRA

Life Insurance

Paid Time Off

Family Leave

Disability

Training

Free Food

Wellness Resources

Stock Options

Résumé du poste

Frontier Medicines seeks two Senior Clinical Trial Managers to lead day-to-day execution of oncology trials, partnering with CROs and trial sites through feasibility, site selection, start-up, and maintenance in a hybrid Boston-based role.

You will own trial documentation, oversee regulatory compliance, monitor timelines, budgets, and quality metrics while supporting study updates and enrollment efforts.

Qualifications

• 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.

Responsabilités

• 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 elevate 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.

Connaissances

Clinical Trial Management

Vendor/CRO management

Oncology experience

ICH-GCP knowledge

Communication skills

Organization & time management

Problem-solving

US work authorization

Formation

Bachelor's degree or RN

Description du poste

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

• 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 elevate 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.