Job Description

Position Summary

• The Project Manager / Sr Project Manager (PM / Sr PM) is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. The PM / Sr PM is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in GCO procedural documents. They are responsible for coordinating and leading the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements. This role actively leads or contributes to process improvement; training and mentoring of other PM\'s and Site Managers (SM). The PM / Sr PM role is often assigned to more complex protocols and can work across Phase 1 - 3 studies in multiple therapeutic areas as needed to drive business needs. They may also perform the role of Clinical Trial Manager (CTM) / Global Trial Lead (GTL) for single country as described in GCO procedural documents.

Key Responsibilities

• Collaborate with Functional Manager (FM) / Clinical Research Manager (CRM) for country protocol feasibility (if applicable) and site feasibility assessment. Implements any local criteria for site selection. Ensure consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country feasibility report. Recommends suitable sites for selection to participate in trial.
• Leads and coordinates local trial team activities in compliance with SOPs, other procedural documents and applicable regulations. Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget. Including but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
• Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate.
• Monitors country progress and initiates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams. Works with SM to ensure CAPA is implemented for audits and inspection or any quality related visits
• Conducts local trial team meetings and provides or facilitates SM training when needed (i.e. implementation of study amendment-and changes in study related processes).
• Reviews and approves Monitoring Visit Reports submitted by SM; identifies issues and/or trends across a trial project and escalates deviation issues to the CTM/GTL and FM as needed
• Reviews and approves site and local vendor services / selection / invoices as required. Manages local study supply, as required.
• Prepares country specific informed consent in accordance with procedural document/templates. Reviews and manages site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations.
• Organizes and ensures IEC/HA approvals, if applicable, and ensure that the trial is in compliance with local regulatory requirements.
• Acts as subject matter expert for assigned protocols. Develops strong therapeutic knowledge to support roles and responsibilities. May represent GCO on cross functional teams.

Key Liaison (Internal / External)

• Primary Reporting Structure: Reports to Functional Manager
• Primary interfaces: Functional Manager, Study Responsible Physicians (SRP), Quality & Compliance Managers/Specialists, Local Safety Officer
• Other Internal Interfaces: R&D Country Head, Regional Therapeutic Area Experts (RTAEs), Contracts & Grants, R&D study team (e.g., SRP), data management and Medical Affairs (when applicable)
• External Interfaces: Trial Site Personnel, external vendor representatives, Ethics Committee and others as required

Key Requirement:

• A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
• Minimum of four years of pharmaceutical and/or clinical trial experience is preferred (including site monitoring experience), however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate\'s eligibility.
• Specific therapeutic area experience may be required depending on the position. Should have solid understanding of the drug development process including GCP and local regulatory requirements. Willingness to travel with occasional overnight stay away from home.
• Strong leadership skills. Solid communication and computer skills required. Proficient in speaking and writing the country language and English language. Excellent written and oral communication skills
• Strong experience in mentoring/coaching and providing training to other LTMs, SMs and CTAs. Demonstrated ability to lead initiative/small teams.
• Flexible mindset and ability to work in a fast-changing environment. Ability to work on multiple trials in parallel in different disease areas, if required.

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