Director Project Delivery

Warszawa - Poland

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities resourcing and Functional Service (FSP) solutions.

Join Our Team as a Director Project Delivery - home based in Poland Portugal Italy Sweden or UK.

About this role

We are seeking an experienced and dedicated Line Manager to lead our Trial Master File (TMF) and Clinical Research Associate (CRA) functional teams within the dynamic Ophthalmology Business Unit.

This critical role involves strategic oversight team leadership and operational management to ensure the efficient execution of clinical trials and the maintenance of regulatory compliance.

Key Responsibilities:

Team Leadership & Line Management:

Provide strong leadership mentorship and line management to a team of TMF Specialists and Clinical Research Associates fostering a culture of accountability excellence and continuous improvement.

Manage day-to-day resourcing activities including workload balancing task delegation and resource allocation across various clinical studies to ensure project milestones are met efficiently.

Oversee performance management processes including goal setting regular feedback career development planning and conducting annual performance reviews.

Oversight of KPIs:

Establish monitor and report on corporate and role-based Key Performance Indicators (KPIs) for both the TMF and CRA teams.

Utilize KPI data to identify trends drive process improvements and ensure functional teams are meeting performance targets and quality standards.

TMF Strategy & Budgeting:

Hold responsibility for supporting TMF-related activities during the pre-award budget planning phase including resource estimation and proposal input.

Contribute to the operational strategy for TMF management ensuring inspection readiness data integrity and compliance with all applicable regulations (GCP ICH guidelines etc.).

Drive the implementation and adoption of TMF systems and best practices within the Ophthalmology unit.

Operational Excellence & Compliance:

Ensure all clinical operations activities particularly those related to the TMF and site monitoring adhere strictly to Standard Operating Procedures (SOPs) Good Clinical Practice (GCP) and regulatory requirements.

Act as a subject matter expert during internal/external audits and regulatory inspections pertaining to TMF documentation.

Collaborate cross-functionally with OPH Project team BD TFS Subject Matter Experts and OPH Leadership teams to streamline processes and achieve operational synergies.

Qualifications:

A Bachelor of Science (BSc) or masters degree in life science

Minimum 9 years relevant experience in pharmaceutical or CRO industry with increasing levels of responsibility including line management of Trial Master File and Clinical Research Associate Teams

Strong knowledge of regulations standards and guidelines such as ICH E6 21 CFR Part 11

Strong leadership skills.

Relevant therapeutic area experience

Experience in project management people management problem-solving and team leadership

Ability to deal effectively with sponsors and internal customers at all levels

Willingness and ability to travel on occasion

Excellent verbal and written communication skills

What We Offer

We provide a competitive compensation package comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. Youll be joining a team that values collaboration innovation and making a difference in the lives of patients

A Bit More About Us

Our journey began over 29 years ago in Sweden in the city of Lund. As a full-service global Contract Research Organization (CRO) we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology Neuroscience Oncology and Ophthalmology.

Our core values of Trust Quality Passion Flexibility and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments resulting in high employee engagement and satisfaction. By aligning on these fundamental values we cultivate a unified force geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration.

Together we make a difference.