Associate Country Project Manager

About the Role

Manages assigned studies to ensure delivery within agreed schedule and quality requirements. Effectively executes the prime contract at a local level by implementing the global study strategy and proactively managing risks for the best possible outcome for the business. Positively represents the company to external stakeholders, providing excellent customer service and operational excellence. Interprets data on project issues and makes sound business decisions with support from experienced team members or line manager.

Works closely with global functional departments and sites to ensure that all deliverables meet or exceed the customer's time, quality, and cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope. Motivates and inspires local teams to keep studies on track to a successful outcome and capitalizes on opportunities arising throughout the lifecycle of the study. Typically works on standard projects of low to moderate complexity. May be frequently assigned as local support on global and/or multi-country studies, supporting the global study lead to ensure smooth communication as well as successful and timely delivery at the local level.

Responsibilities

• Acts as the lead study reference for assigned projects, providing global, territorial, and site-level oversight and leadership. Manages local clinical operational and quality aspects in compliance with company quality framework, ICH GCP, and international standards throughout the entire lifecycle from initiation to close-out.
• Supports more complex studies by working closely with senior Clinical Project Managers (CPMs).
• Coordinates start-up activities or collaborates with the global start-up team for certain projects. Facilitates successful site qualification visits, site initiation visits, and timely ethics committee and regulatory submissions (if appropriate). Reviews and follows up on questions raised by ethics committees.
• Ensures potential rate-limiting factors (e.g., drug supply, vendors) are identified and managed to maintain seamless recruitment.
• Continuously measures and assesses study performance by collecting and analyzing study metrics to predict future status and progress, ensuring contractual obligations are met or organizing contract amendments as necessary.
• Regularly reviews projects using tracking and management tools, provides status updates to leadership, identifies risks, implements proactive solutions, and escalates problems appropriately and in a timely manner.
• Monitors and analyzes recruitment methods against results in collaboration with GEO and pre-identification, processing, and retention of patients at sites to ensure a strong study funnel. Implements strategic changes during the study and provides feedback to appropriate departments for future learnings.
• Ensures timely setup, organization, content, quality, and archiving of the relevant sections of the local Trial Master File, if applicable. Maintains files, including contract logs, amendment logs, and other documents.
• Collaborates with the clinical team and other departments to meet project deliverables. Leads team meetings to ensure timelines, resources, interactions, and quality are maintained.
• Communicates with study sites regarding protocol, patient participation, case report form completion, and other study-related issues.
• Highlights to management and finance if additional budget is required to deliver the study on or ahead of target. Provides financial/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 and contract aspects, and discussing additional patient allocation with the client if the study is likely to be over-recruited.

Requirements

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
• Previous experience comparable to 2+ years in a relevant role. In some cases, an equivalency consisting of a combination of appropriate education, training, and/or directly related experience may be considered sufficient.

Skills

• Good planning and organizational skills to enable effective prioritization of workload.
• Solid interpersonal and problem-solving skills to work in a multicultural matrix organization.
• Capable of working effectively in a changing environment with complex or ambiguous situations.
• Familiarity with the practices, processes, and requirements of clinical research.
• Good judgment and decision-making skills.
• Effective oral and written communication skills, including English language proficiency.
• Capable of evaluating workload against project budget and adjusting 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 to effectively use automated systems and applications such as Outlook, Excel, Word, etc.

Schedule

Standard (Monday–Friday).

Environmental Conditions

• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional domestic and international travel.
• Role can be either office-based or remote.

Physical Requirements

• Frequently stationary for 6–8 hours per day.
• Repetitive hand movement with the ability to make fast, simple, repeated movements of the 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 moves) objects, including luggage and laptop computer, 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 so others will understand; ability to listen to and understand information presented through spoken words and sentences.
• Frequently interacts with others to obtain or relate information to diverse groups.
• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals.
• Requires multiple periods of intense concentration.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to occurrence.
• Ability to perform under stress and multi-task.
• Regular and consistent attendance.