Clinical Operations Lead - FSP

Benefits

Additional Information

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. The Clinical Operations Lead (COL) leads Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Client Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. The COL may perform site monitoring as needed to support the flexible capacity model. The COL is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived. Key Accountabilities: Trial and Site Administration: Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality. Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies. Leads and optimizes the performance of the Local Study Team(s) at country level ensuring compliance with client Procedural Documents, ICH-GCP and local regulations. Ensures, as required, 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. Plans and coordinates applicable to local drug activities (from local purchase or reimbursement to drug destruction). Sets up and maintains the study in CTMS at study country level and 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 (as required and following Client SOPs) and pro-actively 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. Organizes regular Local Study Team meetings on an agenda driven basis. Actively 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/ Global Study Team including Site Management and Monitoring (SMM) Lead. Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary. Develops, maintains and reviews risk management plans on country study level; proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed. Communicates and co-ordinates regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable. Plans and leads National Investigator meetings, in line with local codes, as required. Assists in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies. Participates in training and coaching new members of the Local Study Team ensuring compliance with ICH-GCP and client Procedural Documents. Plans and leads activities associated with audits and regulatory inspections in liaison with Clinical Quality Associate Director (CQAD) and QA. Provides input to process development and improvement. Provides regular information to Line Managers at country level on study/ies and planned study milestones/key issues. Updates Line Managers about the performance of the CRAs/CSAs. Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. Collaborates with local Medical Affairs team. Supports SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management. Document Management: Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant client SOPs and local regulations. Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enroll, and in line with Client SOPs. Ensures completene