Country Project Manager

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – To enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.

Alongside clinical research through our PPD® clinical research portfolio, our work in Trialmed optimizes each step of the patient journey in clinical trials, such as securing sites and recruiting patients, allowing for more patients to participate in clinical research. Your determination to put patients at the heart of every decision will improve health outcomes that people and communities depend on – now and in the future.

Summarized Purpose: 

Manages multiple assigned key 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 complex issues and makes good business decisions with minimal support. 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 capitalise on opportunities arising throughout the lifecycle of the study. Typically works independently on projects of high complexity and varying degrees of unique study challenges (accelerated timelines, new indication etc.). Will further act as role model and mentor to less experienced CPM staff and support them in their daily duties. May be assigned as local support on global and/or multicountry studies supporting the global study lead to ensure smooth communication as well as successful and timely delivery at local level.

Essential Functions and Other Job Information:

• Acts as the lead study reference, for assigned projects which are typically of high 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.
• For certain projects, manages all 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 withGEO 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.
• Provides support, training and mentorship to other CPM staff in their day-to-day duties as needed and may further take on additional responsibilities such as process improvements, managing complex programs and project coordination responsibilities.

Qualifications: 
Education and Experience: 
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 8+ years).

Knowledge, Skills and Abilities:  ​

• Strong leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
• Strong planning and organizational skills to enable effective prioritization of workload and workload of team members
• Strong interpersonal and problem solving skills to enable working in a multicultural matrix organization 
• Solid understanding of change management principles 
• Comprehensive understanding of the practices, processes, and requirements of clinical research
• Strong judgment, decision making, escalation, and risk management skills
• Effective oral and written communication skills, including English language proficiency
• Capable of evaluating own and team members workload against project budget and adjust resources accordingly
• Strong financial acumen and knowledge of budgeting, forecasting and fiscal management 
• Strong attention to detail
• In-depth understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
• Strong computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
• Capable of independently managing clinical studies

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.