Sr. Manager- Clinical Operations

Bridgeway Partners, Inc.; United States; On-site; USD 120,000 - 160,000; Full time

Job summary

Bridgeway Partners, Inc. is seeking a Senior Manager of Clinical Operations for a one-year contract to oversee multiple Phase I studies.

The role is remote with 20–30% travel, primarily to clinical sites in Toronto, Canada, with some weekend travel possible depending on study schedules. The ideal candidate has 6+ years in clinical research or operations within pharma/biotech/CRO environments and strong leadership skills to manage sites, CROs, and external vendors while ensuring regulatory

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Pharmacy or related discipline.
• 6+ years of clinical research, clinical development or clinical operations experience in pharma/biotech/CRO environments.
• Experience leading Phase I clinical trials and managing multiple studies in a fast-paced setting.
• Experience with clinical sites, CROs and external vendors.

Responsibilities

• Lead planning, execution and operational oversight of multiple Phase I clinical studies.
• Manage timelines, deliverables, budgets and study milestones.
• Coordinate site activities including enrollment, dosing visits, monitoring and study execution.
• Oversee CROs, sites and external vendors, including reviewing RFPs, contracts and monitoring reports.
• Collaborate with Clinical Development, Regulatory Affairs, Quality and Medical Affairs.
• Participate in protocol reviews and provide input on study design and feasibility.
• Review CSRs for accuracy and timely completion.
• Identify and resolve operational challenges while ensuring GCP compliance.
• Travel to clinical sites as needed to support study execution.

Skills

Project management

Communication

Organizational skills

Independent work

Travel flexibility

Education

Bachelor's degree in Life Sciences, Nursing, Pharmacy or related discipline

Job description

Senior Manager, Clinical Operations – Pharma/Biotech

One-Year Contract

20–30% Travel

Position Overview

We are partnering with a growing pharmaceutical company to identify an experienced Senior Manager of Clinical Operations for a one-year contract opportunity. This individual will play an integral role in managing multiple clinical studies, with a particular focus on fast-paced Phase I programs.

This is a hands-on opportunity for someone who enjoys taking ownership of clinical trials, working closely with cross-functional teams and managing the operational demands of a growing clinical pipeline.

The ideal candidate will have experience in pharmaceutical, biotechnology or CRO environments.

This position is remote, with approximately 20–30% travel, primarily to clinical sites in Toronto, Canada. Some travel may occur on weekends depending on study schedules.

Key Responsibilities

• Lead the planning, execution and operational oversight of multiple clinical studies, primarily Phase I programs.
• Manage clinical trial timelines, deliverables, budgets and study milestones.
• Coordinate clinical site activities, including patient enrollment, dosing visits, monitoring and study execution.
• Oversee CROs, clinical sites and external vendors, including reviewing RFPs, contracts, change orders and monitoring reports.
• Collaborate with Clinical Development, Regulatory Affairs, Quality, Medical Affairs and other cross-functional teams.
• Participate in clinical protocol reviews and provide input on study design and operational feasibility.
• Review clinical study documentation, including clinical study reports (CSRs), to ensure accuracy, quality and timely completion.
• Identify and resolve operational challenges while maintaining compliance with applicable regulatory requirements and Good Clinical Practice (GCP).
• Travel to clinical sites as needed to support study execution and dosing activities.

Required Qualifications

• Bachelor's degree in Life Sciences, Nursing, Pharmacy or a related discipline.
• Minimum of 6 years of clinical research, clinical development or clinical operations experience within pharmaceutical, biotechnology or CRO environments.
• Experience managing or providing significant operational leadership for Phase I clinical trials.
• Demonstrated ability to manage multiple clinical studies simultaneously in a fast-paced environment.
• Experience working with clinical sites, CROs and external vendors.
• Working knowledge of ICH-GCP, FDA regulations and clinical research requirements.
• Strong organizational, communication and project management skills.
• Ability to work independently, manage competing priorities and adapt to changing study schedules.
• Willingness to travel approximately 20–30%, including occasional weekends and international travel to Canada.

Preferred Qualifications

• Experience with respiratory, pulmonary or inhalation drug development but not a requirement.
• Background supporting generic pharmaceutical development or first-in-human clinical trials.
• Experience with clinical protocol development, study design or clinical endpoints.
• Previous experience working within a startup or growing biotechnology organization.
• Familiarity with clinical trial management systems, electronic trial master files and regulatory submissions.

This is a 12-month contract assignment with a growing pharmaceutical company. The position offers the opportunity to work across multiple clinical development programs and take on meaningful responsibility within a small, collaborative team.

There may be an opportunity for contract extension or conversion to a permanent position based on business needs and performance; however, neither is guaranteed.

Approximately 20–30% travel, primarily to Toronto, Canada. Candidates must have flexibility for occasional weekend travel based on clinical study schedules.