Study Manager, Global Study Management - FPS

Thermo Fisher Scientific

4d•Onsite

About The Position

This position within GCSD works cross-functionally with internal (e.g., LOC) and external partners (e.g., vendors) to deliver delegated operational tasks from CSI (Commit to Study Initiation) until study archiving to time, quality, budget, company standards, and scientific requirements as outlined in the clinical study protocol. The SM is accountable for the delivery of delegated operational tasks to time, quality, budget, company standards, and scientific requirements, supporting decision-making at pace and supporting study teams to achieve overall study deliverables in consultation with the Global Study Lead (GSL) and Global Study Manager (GSM). The SM, as Scrum Master, is responsible for the effective implementation of STOM ways of working and facilitation of key STOM ceremonies. The SM collaborates closely with the Study Leadership Team (SLT) and Working Group (WG) Leads to proactively identify and address obstacles that may impede the study team's progress. Additionally, the SM ensures transparency and alignment across stakeholders by guiding the team in the effective use of collaborative tools (e.g., Jira or other platforms) to track progress, manage workflows, and foster communication.

Requirements

University degree or equivalent, preferably in medical or biological science or discipline associated with clinical studies.
General Science or Life/Health related Science Degree, Scientific area preferred.
A scientific background associated with previous experience in clinical study operations is required.
At least 3+ years of relevant work experience in a pharmaceutical/scientific environment.
Knowledge of clinical trials, drug development process.
Strong knowledge of ICH-GCP, clinical study delivery process, including regulations, operational best practices, industry standards.
Well familiar with key systems used in clinical trial delivery.
Experience in using Trial Master File industry accepted standard.
Project management skills (preferably with analytical/financial skills) and good leadership skills.
Excellent verbal and written communication in English.
Strong communication and relationship building skills, including external service provider management skills.

Responsibilities

Works in close partnership with the GSL and GSM on end-to-end operational study delivery activities, from study setup to study archival, with the focus on overseeing SDS activities and ensuring completeness of internal systems/databases/tracing tools and project plans (CSAP).
Works cross-functionally, with internal and external team members, in accordance with STOM framework, current clinical study regulations and sponsor procedures, policies, best practices and standards, and plays a key role in successful study delivery, providing subject matter expertise across key processes and systems throughout the life cycle of the study.
Clinical study management activities in scope of the SM may include any of the following, agreed in partnership with the GSM and GSL: monitoring study conduct and progress, identifying, resolving and escalating risks/issues which may impact delivery of the study to the necessary quality, timeline and budget objectives and maintaining systems.
Reviewing and leading development of key clinical documents and manuals, including the Protocol and Informed Consent Forms, and leading development of study plans (e.g. Monitoring Plan, Vendor Management Plan, Protocol Deviation Management Plan, Risk Management Plan, Communication Plan, Pharmacy Manual etc.) for external and internal use in assigned studies.
Facilitating and maintaining interactions and meetings with internal (including but not limited to regulatory, LOC, quality assurance, Monitors meeting/Investigators’ Meeting, STOM Ceremonies) and external partners (including CROs and third-party vendors) to ensure the successful delivery of assigned studies.
Support GSM in CRO oversight, overseeing study-specific deliverables, ensuring continued monitoring and timely delivery of activities delegated to third parties.
Vendor management - could serve as a primary point of contact overseeing study-specific deliverables, ensuring continued monitoring and timely delivery of activities delegated to third parties.
Country oversight, acting as a primary point of contact, tracking of recruitment progress, data completeness and compliance, overseeing protocol deviations, risks, regulatory approvals and import license status with support of SDS where appropriate.
Coordinating study-related activities and overseeing study team's communication – meetings, info-spaces, newsletters, action logs, communication plans, team lists with the support of SDS.
Overseeing delivery of clinical supplies, investigational products and all study materials provided by sponsor or external service providers and communicating issues/risks to continuity of supplies and proposing solutions as appropriate.
Data oversight to ensure the study is inspection ready at all times, including oversight of eTMF completeness and SDS deliverables (eTMF setup, periodic reviews, following up on missing documents, Safety Reports Dissemination-), and assure that SDS keeps all eTMF documents complete and verified for quality.
Overseeing of budget tracking done by SDS – managing Task/Change Orders, expenses, tracking updates, checking consistency between systems and agreements and escalating issues to the GSL.
Internal SM can act as a PO owner.
Actively contributes to the Study Leadership Team, Central Study Team and (if necessary) in working groups (Scrum Master role) and acts as a mediator by breaking down barriers, strengthening team dynamics, building business agility and embracing change.
Ambassadors in increasing utilization of AIML tools, driving automation of manual processes, finding efficiencies and more effective ways of working.
Proactive problem solver, able to act independently with minimal input.
Acts as a mentor for less experienced colleagues.
Can play a role of a Subject Matter Expert (SME) in selected systems and processes.
FSP staff oversight (SDS, other as applicable).
Investigator/Monitors’ meeting preparation, coordination and acting as a presenter, where required.
Could serve as a primary point of contact for SSU, Feasibility, Regulatory, DM & CM teams.