Associate Country Project Manager

Thermo Fisher Scientific•Wilmington, NC

1d•Hybrid

About The Position

Manages assigned studies to ensure delivery within agreed schedule and quality requirements. To effectively execute 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 represent the company to external stakeholders, providing excellent customer service and expedited excellence. Interprets data on project issues and makes good 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. Motivate and inspire local teams to keep the studies on track to a successful outcome and capitalize 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 local level.

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).
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.

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 archiving 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.