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For Companies At a Glance
- Tasks: Lead and mentor teams in clinical trial management and ensure regulatory compliance.
- Company: Join TFS HealthScience, a global leader in clinical research.
- Benefits: Competitive salary, comprehensive benefits, and growth opportunities.
- Why this job: Make a real impact in healthcare while leading innovative projects.
- Qualifications: 9+ years in CRO/pharmaceuticals with strong leadership skills.
- Other info: Work remotely from Poland, Portugal, Italy, Sweden, or the UK.
The predicted salary is between 43200 - 72000 £ per year.
Join to apply for the Director Project Delivery role at TFS HealthScience. 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.
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
- 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.
- 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.
- 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.
- 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 master’s 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. You’ll 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.
Director Project Delivery employer: TFS HealthScience
Contact Detail:
TFS HealthScience Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director Project Delivery
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage with professionals on platforms like LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching TFS HealthScience and understanding their values and mission. We want to see that you’re genuinely interested in our work and how you can contribute to our goals. Tailor your responses to show how your experience aligns with the role of Director Project Delivery.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to refine your answers and boost your confidence. We recommend focusing on your leadership skills and how you’ve successfully managed teams in the past, as this is crucial for the role.
✨Tip Number 4
Don’t forget to follow up after your interview! A simple thank-you email can go a long way in showing your appreciation and keeping you top of mind. We love candidates who take the initiative and show enthusiasm for the position.
We think you need these skills to ace Director Project Delivery
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Director Project Delivery role. Highlight your experience in managing TMF and CRA teams, and don’t forget to showcase your leadership skills and relevant qualifications.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for this role. Mention specific experiences that align with the responsibilities outlined in the job description.
Showcase Your Achievements: When detailing your past roles, focus on your achievements rather than just duties. Use metrics where possible to demonstrate how you’ve driven success in previous projects or teams.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and ensure it gets the attention it deserves!
How to prepare for a job interview at TFS HealthScience
✨Know Your Stuff
Make sure you brush up on your knowledge of the pharmaceutical and CRO industry, especially around TMF and CRA processes. Familiarise yourself with regulations like ICH E6 and 21 CFR Part 11, as these will likely come up in conversation.
✨Showcase Your Leadership Skills
Prepare examples that highlight your leadership experience, particularly in managing teams and driving performance. Think about specific situations where you fostered accountability and excellence within your team, as this role requires strong mentorship capabilities.
✨Be Ready to Discuss KPIs
Since the role involves oversight of KPIs, be prepared to discuss how you've used KPI data in the past to drive improvements. Have a few examples ready that demonstrate your ability to monitor performance and implement changes based on data insights.
✨Cultural Fit Matters
Understand TFS HealthScience's core values: Trust, Quality, Passion, Flexibility, and Sustainability. Be ready to explain how your personal values align with theirs and how you can contribute to their collaborative culture.
