Clinical Trial Manager

cAMPfield Therapeutics; Boston (MA); Presencial; USD 120.000 - 160.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Foundational role in biotech start-up

Collaborative, science-driven culture

Shape office environment

Descripción de la vacante

cAMPfield is seeking a Clinical Trial Manager (aCTM) to drive day-to-day operations of clinical studies from startup to closeout. The role oversees CROs, vendors, timelines, budgets, and inspection-ready execution in a fast-paced biotech setting.

Ideal candidates have 5+ years in clinical operations with direct CTM ownership, strong ICH-GCP knowledge, and proven cross-functional leadership in small biotech environments.

Formación

• Bachelor’s in life sciences or related field; advanced degree preferred.
• 5+ years of clinical operations experience with CTM ownership.
• Strong knowledge of ICH-GCP, trial processes, and vendor oversight.

Responsabilidades

• Support startup through closeout across studies; manage CROs and vendors.
• Develop study plans, protocols, ICFs, training materials.
• Ensure studies follow ICH-GCP and regulatory requirements.
• Lead cross-functional study team meetings; coordinate with various functions.
• Oversee data management, TMF completeness, and study closeout activities.

Conocimientos

Clinical operations

CTM ownership

Vendor oversight

ICH-GCP

Cross-functional leadership

Educación

Bachelor’s degree in life sciences

Advanced degree preferred

Descripción del empleo

cAMPfield is a clinical-stage biopharmaceutical company focused on developing well-tolerated and highly effective oral medicines, founded and led by industry veterans with success developing therapies for immune-mediated inflammatory diseases, including inflammatory bowel disease (IBD).

About the Role

The Clinical Trial Manager (aCTM) is responsible for supporting the day‑to‑day management of clinical studies from startup through closeout. This role is ideal for someone who is energized by cross‑functional collaboration, proactive problem‑solving, and the pace of an emerging biotech. The CTM will oversee CROs, vendors, timelines, budgets, and ensure inspection‑ready execution across all phases of the trial.

Key Responsibilities

• Support the overall operational planning, study startup, site selection, and activation activities under the direction of senior Clinical Operations leadership.
• Assist in the development and review of core study documents (protocols, ICFs, etc.) and drive the development of study plans, manuals, and training materials.
• Ensure studies are conducted in accordance with ICH‑GCP, regulatory requirements, and internal SOPs.
• Serve as the day-to-day operational contact for CROs and external vendors, supporting escalations to senior Clinical Operations leadership as appropriate.
• Oversee monitoring activities, enrollment performance, site engagement, and risk mitigation.
• Review vendor deliverables, KPIs, and quality metrics; elevation issues proactively.

Clinical Operations Leadership

• Assists with the overall management of study timelines, budgets, and forecasting; support contract and SOW development.
• Lead cross‑functional study team meetings and ensure alignment across Clinical Development, Biometrics, Safety, and Regulatory.
• Support inspection readiness and contribute to audit responses and CAPAs.

Data & Quality Oversight

• Partner with Data Management on database build, data cleaning, and query resolution.
• Review clinical data listings, safety narratives, and protocol deviations.
• Ensure high‑quality documentation and TMF completeness.

Study Closeout

• Oversee site closeout, reconciliation activities, and final study reporting.
• Contribute to CSR development and lessons‑learned processes.

Qualifications

• Bachelor’s degree in life sciences or related field; advanced degree preferred.
• 5+ years of clinical operations experience in biotech/pharma, with direct CTM‑level ownership of clinical studies.
• Strong understanding of ICH‑GCP, clinical trial processes, and vendor oversight.
• Experience working in small or emerging biotech environments strongly preferred.
• Ability to manage multiple priorities, anticipate issues, and comfortable operating with a high degree of autonomy as well as under the guidance of senior team members.
• Excellent communication, organization, and cross‑functional leadership skills.

What We Offer

• The opportunity to play a foundational role in a mission‑driven biotech start‑up.
• A collaborative, science‑driven culture where operational excellence is valued.
• The ability to shape the office environment and operational backbone of a growing company.