Associate Country Project Manager

Thermo Fisher Scientific is a healthcare and clinical research company advancing innovative solutions for clinical studies. The Associate Country Project Manager manages assigned local clinical studies from initiation through close-out, ensuring delivery within schedule, quality, and contract requirements. The role leads study operations, coordinates with global teams and sites, manages risks and budgets, and maintains compliance with applicable regulations and quality standards.

Responsibilities:

• Acts as the lead study reference, for assigned projects which are typically of low to moderate complexity, providing global, territorial and site-level oversight and leadership and managing local clinical operational and quality aspects in compliance with company quality framework, ICH GCP and international standards throughout the entire life cycle from initiation to close-out
• Acts as a supporting colleague on more complex studies working closely with more senior CPMs
• For certain projects, coordinates start-up activities or works in collaboration with the global start-up team. Facilitates successful site qualification visits and site initiation visits as well as timely ethics committee and regulatory submissions (if appropriate). Reviews and follows up on all questions raised by the ethics committees. Ensures potential rate limiting factors (e.g. drug supply, vendors) are identified and managed to ensure maximum and seamless recruitment
• Continuously measures and assesses study performance by collecting and analyzing study metrics to determine where the study stands and to predict future status and progress with the overall goal to ensure that contractual obligations are met (or organizing contract amendments as necessary). Regularly reviews projects using tracking and management tools, provides status updates to the O&SS Lead, identifies risks and implements proactive solutions and recovery actions, identifies problems and escalates 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 against target to ensure a strong study funnel and to help implement changes to the strategy during the study and at close, with feedback to appropriate departments to ensure future learnings
• Ensures timely set up, organization, content, quality and archving of the relevant sections of the local Trial Master File if applicable. Maintains files, incl. contract logs, amendment logs and other documents
• Collaborates with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicates with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained
• Communicates with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues
• Highlights to management and finance if additional budget is required to deliver study on or ahead of target. Provides financial/invoicing support to finance teams to ensure invoices are paid and queries are resolved in a timely manner
• Acts as the overall study lead for local studies managing such studies from award through to close-out including budget and contract aspects and discussion with the client around additional patient allocation if the study is likely to be overrecruited

Requirements:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
• In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
• Good planning and organizational skills to enable effective prioritization of workload
• Solid interpersonal and problem solving skills to enable working in a multicultural matrix organization
• Capable of working effectively in a changing environment with complex/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, etc
• Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc
• Occasional drives to site locations with occasional travel both domestic and international
• Role can be either office or remote based
• Frequently stationary for 6-8 hours per day
• Repetitive hand movement of both hands 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 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 developed both in-house and off-the-shelf
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas 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 the occurrence. Ability to perform under stress. Ability to multi-task
• Regular and consistent attendance