Associate Country Project Manager

Manages assigned studies to ensure delivery within agreed schedule and quality requirements. Implements the global study strategy at a local level, proactively managing risks and representing the company to external stakeholders with excellent customer service.

Responsibilities

• Acts as the lead study reference for assigned projects of low to moderate complexity, providing oversight and leadership at global, territorial, and site levels, ensuring compliance with company quality framework, ICH GCP, and international standards throughout the study lifecycle.
• Supports more complex studies, collaborating with senior Clinical Project Managers (CPMs).
• Coordinates or supports start-up activities, including site qualification visits, site initiation visits, and timely ethics committee and regulatory submissions.
• Reviews and follows up on questions raised by ethics committees.
• Identifies and manages potential rate-limiting factors (e.g., drug supply, vendors) to ensure seamless recruitment.
• Continuously measures and assesses study performance using metrics to predict progress and ensure contractual obligations are met, organizing contract amendments as needed.
• Regularly reviews projects using tracking and management tools, providing status updates, identifying risks, implementing solutions, and escalating problems appropriately.
• Monitors and analyzes recruitment methods and patient retention, collaborating with GEO and other teams to adjust strategies and provide feedback for future learnings.
• Ensures timely setup, organization, content, quality, and archiving of the local Trial Master File, if applicable, and maintains files including contract logs and amendment logs.
• Collaborates with clinical teams and other departments to meet project deliverables.
• Leads team meetings to maintain timelines, resources, interactions, and quality.
• Communicates with study sites on protocol, patient participation, case report form completion, and other study-related issues.
• Highlights budget needs to management and finance to ensure studies are delivered on or ahead of target.
• Provides financial and invoicing support to ensure timely payment and resolution of queries.
• Acts as the overall study lead for local studies, managing them from award through close-out, including budget, contract aspects, and discussions with clients regarding additional patient allocation if overrecruitment is likely.

Requirements

• Bachelor’s degree or equivalent and relevant formal academic/vocational qualification.
• 2+ years of comparable experience; equivalency through a combination of education, training, and directly related experience may be considered.

Skills

• Good planning and organizational skills to prioritize workload effectively.
• Solid interpersonal and problem-solving skills for working in a multicultural matrix organization.
• Ability to work effectively in a changing environment with complex or ambiguous situations.
• Familiarity with clinical research practices, processes, and requirements.
• Good judgment and decision-making skills.
• Effective oral and written communication skills, including English language proficiency.
• Ability to evaluate workload against project budget and adjust resources accordingly.
• Sound financial acumen and knowledge of budgeting, forecasting, and fiscal management.
• Strong attention to detail.
• Solid understanding of relevant regulations (e.g., ICH/GCP, FDA guidelines).
• Good computer skills, including proficiency in Outlook, Excel, Word, and other automated systems.

Schedule

Standard (Monday–Friday)

Environmental Conditions

• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional travel to site locations, including domestic and international trips.
• Role may be office-based or remote.

Physical Requirements

• Frequently stationary for 6–8 hours per day.
• Repetitive hand movements, including fast, simple, repeated movements of fingers, hands, and wrists.
• Frequent mobility required.
• Occasional crouching, stooping, bending, and twisting of the upper body and neck.
• Light to moderate lifting and carrying (or otherwise moving) objects, including luggage and laptop, with a maximum lift of 15–20 lbs.
• Ability to access and use a variety of computer software, both in-house and off-the-shelf.
• Ability to communicate information and ideas clearly and listen to others effectively.
• Frequent interaction with diverse groups to obtain or relay information.
• Works independently with minimal guidance, planning work schedules to meet goals.
• Requires multiple periods of intense concentration.
• Performs a wide range of variable tasks with little predictability in occurrence.
• Ability to perform under stress and multitask.
• Regular and consistent attendance.