Senior Oncology Trial Manager - Hybrid, End-to-End Ops

Xtalks; Boston (MA); Hybrid; USD 125,000 - 170,000; Full time

Benefits offered by this job

Health plan

401k/IRA

Life Insurance

Paid Time Off

Family Leave

Disability

Training

Free Food

Wellness Resources

Stock Options

Job summary

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.

Responsibilities

• 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.

Skills

Clinical Trial Management

Vendor/CRO management

Oncology experience

ICH-GCP knowledge

Communication skills

Organization & time management

Problem-solving

US work authorization

Education

Bachelor's degree or RN

Job description

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.