Clinical Team Manager FSP - Country Study Manager

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

The Clinical Trial Manager is accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. The Clinical Trial Manager interprets data on project issues and makes good business decisions with support from experienced team members or line manager. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. The position involves working on projects of low to moderate complexity and as part of a team of CTMs.

− Works in an environment that is constantly evolving with new processes and systems, internally and externally and the CSM needs to be able to adapt to these changes quickly and efficiently. Flexible and resilient with ability to evolve in changing and challenging environment.

− Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives.

− Demonstrates an excellent understanding of the clinical study, drug development, sample management and other associated processes and quality requirements.

− Strong project management mindset and demonstrated ability to work and lead in a matrix team environment involving both internal (client) and external partners.

− Able to represent client to external physician investigators and other external clinical site staff, institutional review boards, etc., including the ability to answer complex questions

− Able to work effectively within the local environment and collaborate extensively with geographically distant central team members. Ability to work effectively in a remote environment.

− Able to set and manage priorities and performance targets in a local environment.

− Effectively plans, communicates, coordinates and facilitates delivery of team objectives.

− Solid understanding of country local regulations, ICH-GCP guidelines and client written standards.

− Available and willing to travel for project related activities as required (e.g. Investigator & Monitors Meeting attendance.

− Acts as role model in line with client core values and behaviors.

− Able to understand the impact of technology on studies and to use/develop computer skills while making appropriate use of client systems/software.

− Demonstrates conceptual, analytical and strategic thinking.

− Effective at problem solving and conflict resolution.

− Demonstrates good English language written and verbal communication skills in addition to proven negotiation skills.

− Flexible with high learning agility.

− Strong computer skills

Role Description:

The Country Study Manager (CSM) is pivotal to trial delivery and compound development for the global R&D organization, providing leadership and driving decisions related to the conduct of a clinical trial. The CSM leads and manages the operational implementation of country feasibility, planning and delivery of R&D Pharma Phase I-IV clinical studies within and across therapeutic areas. The CSM serves as the operational point-of-contact between the Central Study Team and in-country staff aligned to the study.

Accountable for high quality execution/delivery of studies within country as defined by the protocol & per agreed timelines / budget; overall project management of study activities.

− With limited oversight:

• May provide input into the study concept, protocol, logistics and may co-ordinate other expert local input

• Assess appropriateness of study for local environment.

• Conducts country/site feasibility.

• Leads selection of sites within country; accountable for site performance.

• Ensures development and maintenance of country study plan and forecast, including budgets, resource estimates, milestones, timelines, quality, and risk planning.

• Selects & manages local vendors in accordance with local practices & in alignment with overall resourcing strategy for the study; accountable for vendor management including oversight, agreements, payments, communications & issue management.

• Accountable for the creation and management of study budgets (budget updates, expenditures including site payments across a study) and reporting of accrual to finance department.

− With oversight:

• Manages the development of key study documents, plans & manuals according to local requirements (e.g., monitoring plan, local informed consent form, import/export licenses etc.); develops local recruitment and other site support materials.

• Ensures development of country / site-level study risk assessment to proactively identify areas at risk, develop a mitigation plan and communicate to management and study teams locally and globally.

− Responsible for assisting with (in accordance with local regulations and client LOC standard practice) the ethics committee/IRB submissions. In some cases, may also be accountable for Regulatory Authority submissions and approvals.

− Arranges accurate translations of key study documentation into local language as required.

− Provides support / develops and negotiates Clinical Trial Agreements (depending on client local practices) with the investigational sites, ensuring legal input where required.

− Ensures necessary supplies are available at sites and manages local supply inventory.

− Ensures in-country study oversight: coordinates local internal & external operational activities; maintains clear visibility to sites’ progress and issues; reviews in-country protocol deviations; metrics; manages in-country study communications; ensures appropriate issue escalation & follow-through within country and above country; communicates status/issues effectively to central team; ensures monitoring plan is followed.

− Build close working relationships with key partners including local medical staff.

− Ensures appropriate training of in-country staff and investigator sites; coordinates & delivers operational aspects at local study meetings including investigator meetings, monitor meetings and local training.

− Ensure the quality and integrity of clinical studies conducted in the LOC by taking on appropriate business management monitoring activities

− May act as a point of contact for regulatory/compliance audits of assigned study(s); provides input into LOC and site assessment/audit proposals and delivers country response & follow-up to assessment/audit reports.

− Accountable to specify and review in-country study monitoring tracking tools, monitors key risk and performance indicators and other reports. Review all study databases to ensure 100% accuracy.

− Escalates resourcing issues to ensure that in-country study activities are appropriately resourced.

− Ensures robust communication with sites, e.g. timely communication of protocol amendments.

− Reviews and approves all Monitoring Visit Reports (MVRs) for their study(s) within agreed timelines to obtain an understanding of current site status.

− Ensures ongoing management and reporting of study specific safety issues and safety report handling, as required (including SAE reporting).

− Ensures conduct of assigned studies in the country according to all applicable regulations, ICH/GCP and client written standards.

− Reviews, ensures completeness and maintains accuracy of Sponsor Study Records.

− Co-ordinates / contributes to end of study / program learning debriefs and identify areas for improvement.

Acquires and maintains therapeutic area and product specific knowledge for the designated therapy area, study protocol training and all study related activities. Participate continuously in relevant training courses to improve personal/professional skills.

− Keep up to date with all the changes / required knowledge on ICH GCP, client written standards and attending appropriate training sessions.

− Requirement to interact and collaborate with client Country study staff

− Requirement to communicate and work effectively with medical staff/physicians/scientists who are often senior within their field, being mindful of their standing within the medical and/or research community.

− Interactions with key partners including ethics boards, pharmacies, vendors

 

Education & Experience 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 5+ 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.

Knowledge, Skills, Abilities:
• Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
• 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 monitoring
• 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 acument 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.

Working Conditions and Environment:
• Work is performed in an office environment with exposure to electrical office equipment.
• Frequently drives to site locations and frequently travels both domestic and international.

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthroughs.