Study Manager - FSP - EMEA

Work Schedule

Environmental Conditions

Job Description

Study Manager

Role Purpose:

• Study Manager (SM) is a key member of the Global Study Team contributing to delivering the clinical study to time, cost and quality, and ensuring inspection readiness by taking an oversight over study eTMF completeness.
• SM role was implemented to have a broader impact on the business, by driving continuous improvement initiatives within their remit of expertise, sharing best practices across business, with a focus on increasing operational delivery efficiency.

Key Responsibilities:

• SM works in close partnership with the Study Delivery Lead (SDL) on end-to-end operational study delivery activities, from study setup to study archival, with the focus on setting up, maintaining and ensuring completeness of internal systems / databases / tracking tools and project plans (CSAP).
• SM works cross-functionally, with internal and external partners, on clinical study management activities as agreed with the Study Delivery Lead, for in-house and outsourced studies across all phases and therapeutic areas, in accordance with Study Team Operating Model (STOM), 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.
• SM is responsible for 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.
• SM is responsible for reviewing key clinical documents, 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 etc.) for external and internal use in assigned studies.
• SM is responsible for facilitating and maintaining interactions and meetings with internal (including but not limited to regulatory, LOC, quality assurance, Monitors meeting) and external partners (including CROs and third-party vendors) to ensure the successful delivery of assigned studies.
• SM is responsible for vendor management and CRO oversight, acting as a primary point of contact, overseeing study-specific deliverables, ensuring continued monitoring and timely delivery of activities delegated to third parties.
• SM is responsible for 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.
• SM is responsible for coordinating study-related activities and managing study team’s communication – meetings (preparation, scheduling, meeting minutes), info-spaces, newsletters, action logs, communication plans, team lists.
• SM is responsible for 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.
• SM is responsible for data oversight to ensure the study is inspection ready at all times, including oversight of eTMF completeness (eTMF setup, periodic reviews, following up on missing documents, Safety Reports Dissemination), and assure that all eTMF documents are complete and verified for quality.
• SM is responsible for budget oversight – managing Task / Change Orders, expenses, tracking updates, checking consistency between systems and agreements and escalating issues to the SDL.
• SM actively contributes to the squads (potential Scrum Master role in the Global Study Team) and acts as a mediator by breaking down barriers, strengthening team dynamics, building business agility and embracing change.
• SM is responsible for performing full set of activities without assistance and has the ability, and the seniority, to support any types of studies and activities which require clinical trial expertise with limited instructions from the SDL.
• SM acts as a mentor for less experienced colleagues.

Education Requirements (minimum expected):

• University degree or equivalent, preferably in medical or biological science or discipline associated with clinical studies

Role Related Experience (minimum requirements):

• At least 3+ years of relevant work experience in a pharmaceutical/scientific environment.
• Knowledge of clinical trials, drug development process.
• Excellent 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.
• Strong project management skills (preferably with analytical / financial skills) and good leadership skills.
• Excellent verbal and written communication in English.
• Excellent communication and relationship building skills, including external service provider management skills.

Other Role-Related Skills:

• Excellent knowledge of, and skills in applying, applicable clinical trial regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
• Ability to manage multiple competing priorities within various clinical studies with good planning, time management and prioritization skills.
• Ability to think independently, analyse and solve problems systematically and creatively, and to take a risk-based approach.
• A confirmed level of expertise and seniority within the area and function.
• Logical / analytical thinking and an inclination to spot patterns and outliers. Quality mindset, critical sense, attention to details, effective training and mentoring skills.
• Very good understanding of the principles of project planning and management.
• Knowledge of project finance and accounting principles in order to understand budget, invoices, cross-charges and expense reports.
• Excellent comprehension of Microsoft Office tools (Excel, PowerPoint, Word, Outlook, etc.). Knowledge of advanced Excel, timelines/budget tracking systems and clinical trial management systems.
• Excellent stakeholder management and communication skills (oral and written), outstanding interpersonal skills.
• Excellent networking capabilities and ability to influence and manage stakeholders at all levels of the organization, ability to facilitate and lead cross-functional meetings, challenge status quo and inefficient ways of working and be comfortable in a mediator role.
• Results driven and efficient. Motivated and dynamic personality. Able to evolve in a changing and challenging environment, coach the study team members to focus on value, building business agility and embracing change.
• Ability to adjust to work in cross-functional squads in the agile model.
• Team spirit and ability to work across cultures and geographies with a high awareness and understanding of cultural differences.