Study Operations Manager II/Senior Clinical Operations Leader - FSP

Job summary

The Study Operations Manager leads local study teams and oversees CROs to ensure operational delivery from study startup through close. Responsibilities include managing timelines, budgets, recruitment strategies, and regulatory submissions to Health Authorities and Ethics Committees.

Job details

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. The Study Operations Manager has responsibilities for study and regional or specific country level activities from study startup through conduct and study close on one or more studies, providing leadership, strategic planning, and organization skills to ensure the operational delivery of tasks. * Serves as leader of the local study team on one or more studies * Provides back up to or assumes the responsibilities of the GSM as needed * Oversees the preferred Contract Research Organization and/or Country Trial Manager/Site Care Partner for assigned studies at country level in accordance with the overall project plan, and manages and maintains accurate country level plans (e.g., timelines, budget, risk, and quality plans) * May manage the study start up process in countries assigned and/or oversee the CRO responsible for these activities as applicable * Liaises with SCP, Lead SCP, Site Activation Partners and regulatory colleagues in country to agree on submission strategy to Health Authorities (HAs) and Ethics Committees (ECs) * Provides country level input on startup and recruitment milestones during planning * Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required. * Accountable for resolution of site activation escalations to study teams including offering options for mitigation * Fully responsible and accountable for, as designated by the GSM: * Regional, country, and study level implementation of startup and site activation plans * Regional, country and study level recruitment strategy * Development of study level plans * Communication with the local team and internal stakeholders and CRO as applicable to ensure efficient and timely study delivery of the agreed plans * Study and/or country vendor management and oversight including follow up and coordination of vendor deliverables * Assurance of the follow up and coordination of regional and site quality events, protocol deviations, data issues, metrics review, site issues and risks, audit responses, etc. Requirements: * Bachelor’s of Science or Bachelor’s of Arts degree with a minimum 5 years of relevant operational clinical trial experience required * Master’s of Science or Master’s of Business Administration degree with a minimum 3 years of relevant operational clinical trial experience required * A scientific or technical degree is preferred #LI-LO1

What you’ll do

The Study Operations Manager leads local study teams and oversees CROs to ensure operational delivery from study startup through close. Responsibilities include managing timelines, budgets, recruitment strategies, and regulatory submissions to Health Authorities and Ethics Committees.

Requirements

Requires a Bachelor's degree with at least 5 years of operational clinical trial experience or a Master's degree with at least 3 years of experience. A scientific or technical degree is preferred.

Listed skills

• Clinical Operations · Preferred
• Budget · Preferred
• Recruitment · Preferred
• Technical · Preferred
• Organization · Preferred
• Health · Preferred
• Teams · Preferred
• Planning · Preferred
• Assurance · Preferred
• Development · Preferred
• Audit · Preferred
• coordination · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Study Operations Management
• Clinical Trial Execution
• Strategic Planning
• Vendor Management
• Risk Mitigation
• Site Activation
• Regulatory Submission Strategy
• Budget Management
• Recruitment Strategy
• CRO Oversight
• Quality Event Coordination
• Project Planning

Job areas

• Healthcare
• Science & Research
• Management & Leadership
• Consulting