Clinical Trial Study Operations Manager

Clinical Trial Study Operations Manager

The Study Operations Manager I (SOM I) at Parexel takes responsibility for study and regional or country-level activities from startup through conduct and closeout for one or more studies. This role requires leadership, strategic planning, and organizational skills to ensure the operational delivery of tasks.

Key Accountabilities

As a Clinical Trial Study Operations Manager, you will hold several key responsibilities:

• Supports Global Study Managers (GSMs) and other SOMs by leading specific project parts, driving countries, executing complex tasks, and developing solutions.
• Serves as the local study team leader (core members, ad hoc members, and other key stakeholders) for one or more studies.
• Oversees the preferred Contract Research Organization (pCRO) and/or Country Trial Manager (CTM)/Site Care Partner (SCP) at the country level, managing accurate country-level plans (timelines, budget, risk, quality).
• Manages or oversees the study start-up process in assigned countries, including liaising with SAPs and regulatory colleagues for submission strategies.
• Provides country-level input on startup and recruitment milestones to the GSM during planning.
• Collaborates on identifying and managing deviations and risks, implementing mitigation strategies, and resolving site activation escalations.
• May be accountable for regional/country recruitment strategy, development of study level plans, communication with local teams, vendor management, and oversight of quality events, protocol deviations, and audit responses.

Study Management Operations

This role also involves critical operational tasks:

• Acts as the primary point of contact for local study team questions, ensuring resolution or escalation to global teams.
• May lead operational effectiveness initiatives at the country or regional level.
• Utilizes in-country roles (Lead SCP, Contracts Leads, SAPs) to provide local intelligence and operational nuances to global teams.
• Provides input on country-level per subject costs, local vendor costs, and other applicable fees.
• Uses country intelligence for risk input into the Investigational Quality Management Plan and Study Monitoring Plan, ensuring Trial Master File (TMF) completeness and compliance.
• Supports the implementation of client’s site technology experience systems.
• Supports the implementation of new tools and technologies such as eConsent, eISF, remote source access, remote source data verification/review (SDV/SDR), and iConnect.

Compliance with Parexel Standards

Maintaining high standards is crucial:

• Completes all required training curriculum accurately.
• Submits timesheets and expense reports as required.
• Maintains an updated CV reflecting current experience.
• Adheres to Parexel processes, ICH-GCPs, and all other applicable regulatory requirements.

Skills

To succeed in this role, candidates should possess the following skills:

• Expertise in study and site dashboards and reporting tools.
• Detail-oriented with strong technical expertise.
• Ability to manage moderately complex processes.
• Risk identification, mitigation, strategic planning, and critical path analysis skills.
• Strong analytical and problem-solving abilities.
• Adaptability to changing technologies and processes, ability to work independently, and exercise sound judgment.
• Supportive of innovation, including developing ideas and taking appropriate risks.
• Effective verbal and written communication in English, both internally and externally.
• Ability to operate effectively in a matrix environment.
• Flexibility to work outside core business hours for global trials or initiatives.
• Ability to travel as required for Investigator Meetings, vendor kick-offs, and client meetings.

Knowledge And Experience

Successful candidates will bring significant experience and knowledge:

• 3-5 years of clinical trial study management experience is required.
• Comprehensive knowledge of own discipline and good knowledge of other disciplines to achieve study goals.
• Comprehensive experience in managing and coordinating specific tasks within a larger study management team.
• Working knowledge of Good Clinical Practice, clinical and regulatory operations, and the environment in responsible countries.
• Demonstrated clinical research experience and/or study management/startup project manager experience.
• Proven experience in managing country-level operational activities and/or vendors.
• Experience in study and quality management.
• Knowledge of clinical trial methodology.
• Experience working effectively in a matrix management environment.
• Relevant operational clinical trial experience.

Education

The required educational background for this position is:

• A Bachelor’s of Science or Bachelor’s of Arts degree with a minimum of 7 years of relevant operational clinical trial operations experience required.
• Alternatively, a Master’s of Science or Master’s of Business Administration degree with a minimum of 6 years of relevant operational clinical trial experience required.
• A scientific or technical degree is preferred.

Key skills/competency

• Clinical Trial Management
• Study Operations
• Vendor Oversight
• Risk Mitigation
• Regulatory Compliance
• Project Planning
• Site Activation
• ICH-GCP
• Data Management
• Communication