Lead Local Study Director – Remote Home-Based Trials

Amsterdam, Netherlands | Full time | Home-based | R1546449

Lead Local Study Teams (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines, complying with Sponsor Procedural Documents, ICH‑GCP and relevant local regulations. May also perform site monitoring to support the flexible capacity model.

• Has overall responsibility for study commitments within the country and for timely delivery of data to required quality.
• Leads Local Study Team consisting of CRAs and CSAs for assigned study/studies.
• Leads and optimises the performance of the Local Study Team(s) at country level ensuring compliance with Sponsor Procedural Documents, ICH‑GCP and local regulations.
• Ensures that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
• Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
• Ensures timely submission of application/documents to EC/IRB at startup and for the duration of the study; works with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority.
• Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in the Sponsor clinical studies financial system.
• Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.
• Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, including any relevant translations.
• Ensures all country and site level trial essential documents required by ICH‑GCP prior to study start have been collected and verified for correctness.
• Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).
• Sets up and maintains the study in CTMS at the study country level as well as local websites as required by local laws and regulations.
• Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
• Reviews monitoring visit reports and proactively advises the monitor(s) on study related matters.
• Performs any required co‑monitoring, accompanied site visits/training visits with study CRAs.
• Proactively identifies risks and facilitates resolution of complex study problems and issues.
• Organises regular Local Study Team meetings on an agenda‑driven basis.
• Works towards achieving good personal relationships with all Local Study Team members, sites’ staff and global stakeholders.
• Reports study progress/update to the Global Study Associate Director and Global Study Team including the SMM Lead.
• Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary.
• Develops, maintains and reviews risk management plan at country study level; proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are identified, mitigated and managed.
• Communicates and coordinates regularly with the National Co‑ordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable.
• Plans and leads national investigator meeting to ensure all study documents are ready for final archiving and completion of local part of the eTMF.
• Plans and leads activities associated with audits and regulatory inspections in liaison with CQAD and QA.
• Provides input to process development and improvement.
• Provides regular information to Line Managers at country level on study and planned study milestones/key issues.
• Updates Line Managers about the performance of the CRAs/CSAs.
• Ensures that study activities at country level comply with local policies and code of ethics.
• Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
• Ensures compliance with Sponsor Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
• Collaborates with local Medical Affairs team.
• Supports SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management.

• Bachelor degree in a related discipline, preferably in life science, or equivalent qualification.
• Minimum 3 years of experience in Development Operations (CRA, senior CRA) or other related fields (Medical Affairs‑led or Academic‑led studies).
• Good knowledge of international guidelines ICH‑GCP as well as relevant local regulations.
• Proven ability to lead and motivate cross‑functional teams to deliver clinical trials according to or ahead of the time plan, budget and with required quality.
• Good medical knowledge in Oncology, Rare Diseases, cardiology, hematology, CVRM Therapeutic Areas.
• Good knowledge of the Drug Development Process.
• Excellent understanding of the Clinical Study Process including monitoring.
• Very good understanding of the Study Drug Handling Process and the Data Management Process.
• Excellent project management skills.
• Excellent ability to prioritise and handle multiple tasks, attention to details and negotiation skills.
• Excellent knowledge of spoken and written English and Dutch language.
• Good ability to learn and adapt to work with IT systems.
• Ability to travel nationally and internationally as required.