The Manager, Study Start Up and Regulatory Affairs is responsible for developing the strategy based on regulatory requirements and for coordinating and overseeing all SSU deliverables from site selection through site initiation readiness. The manager actively assists senior management in securing new business by participating to BDMs and contributing to proposals/budgets. They also provide strategic regulatory guidance, training, coaching and mentoring to junior members; may be required to line manage members of staff.
Leads study start-up and regulatory activities for assigned projects of medium to high complexity, ensuring delivery aligned with timelines, quality standards, and regulatory requirements.
Accountable for end-to-end delivery of study start-up and regulatory milestones across assigned projects.
Ensure collection, review for completeness/compliance, and tracking of essential documents for
Study Start-Up to facilitate efficient site initiation and activation. Investigate incomplete, inaccurate or missing documents to ensure accuracy and completeness of information. Prepare study team reports or updates regarding status of essential document collection, review and approval.
Ensure negotiation and execution of clinical site agreements, ancillary agreements as well as amendments, in accordance with project requirements and country regulations and within the projected delivery timelines.
Defines and implements study start-up and regulatory strategies at project level, ensuring alignment with sponsor expectations, regulatory requirements, and operational feasibility.
Proactively identifies, assesses, and mitigates risks impacting study start-up and regulatory timelines, ensuring timely resolution of issues.
Builds and maintains strong relationships with clients, regulatory authorities, and internal stakeholders to ensure effective collaboration and delivery.
Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated, monitor project budgets, hours spent vs budgeted and promptly identify and escalate any OoS.
Assist in securing new business or repeated business by participating to BDMs, developing and reviewing regulatory sections of proposals, regulatory costing and budgets.
Provides strategic input into bids and contributes to winning new business opportunities
Provides coaching, guidance, and performance feedback to team members to support development and delivery excellence.
Performs other work-related duties as assigned.
Graduate degree in Chemistry or Life Sciences, Nursing or equivalent combination of education and experience.
6-8 years within pharmaceutical or CRO industry or Regulatory body, of which at least 3 years in a leading/project management role
Proven ability to successfully manage global projects
When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.
We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.
We look forward to welcoming your application.
Job details are sourced from the employer's original posting.
Open job postingAbout the company
Ergomed Group is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease. Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia Our company allows for employee visibility (you have a voice!) creative contribution and realistic career development. We have nourished a true international culture here at Ergomed. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. Come and join us in this exciting journey to make a positive impact in patient’s lives.