Clinical Operations Project Lead

Early participation to address operational aspects in the study country strategy in partnership with relevant parties to ensure a smooth and fast path to the First Patient In:

• Identifies gaps and initiates risks assessment in processes, vendors services and resources

• Lead Country Study Set up to ensure progress according to study timelines with strategic planning

• Review and approve the site selection reports and recommend the final list of sites selected for the study to Cluster/CSU Head for final approval

• Develop and initiate early recruitment and retention strategy and associated materials at local level in collaboration with respective colleagues

Lead local study management at the country level from operational point of view starting with experience sharing during feasibility process, through end of the study according to global and local study plan:

• Attends feasibility meeting to collaborate with SEM and MDA to identify most probably successful sites even for feasibility process

• Initiates early exchange with Medical Affairs to identify important sites and/or new sites

• Participate in the study MDA handover meeting following country allocation

• Organize the Local Kick Off Meeting with respective local study team members

• Prepare and lead Local Investigators Meeting; Participate in the regional/global Investigator Meeting.

• Lead set-up activities to ensure they are within agreed timelines and according to the company standards, ensure SQV and SIV readiness including proper materials, ensure proper site management, revision and closures are done according to plan.

• Accounts for the set-up, completion, and adaptations of project management tools at country level (CTMS, Control room…)

• Performance of the study: drives risk assessment and develop contingency planning and risk-mitigation strategies at country level; adapt and implement the recruitment and retention plan at local level, follow and mitigate in order to reach recruitment targets within agreed timelines.

• Aligns with Site Partnership Manager (SPM) on activities to engage with sites: calls & meetings for site engagement regarding site motivation and performance or other study related topics, Participate in SIVs as needed

• Provides support to site staff and monitoring team in the conduct of clinical trials.

• Oversees Country Supplies Strategy and Planning including assessment and mitigation of local risks

• Anticipates and initiates requests for reimbursements in accordance with the Operational Procedure, as well as post-study access in relation to clinical trials.

Oversees Study Budget at country/cluster level and ensures optimization and appropriate management of the financial resources:

• Collaborate with Start Up Strategic Manager (SUSM) for preparation of LSCR (local study cost request) ensuring cost optimization and appropriate projection at the beginning of the study

• Manage and maintain Country Study Budget during course of study

• Progress review of planned vs actual spends

• Ensure timely escalation of issues / risks related to the country budget and initiate LSCR updates

Promote effective communication between all parties involved in the study to align common goals and define effective strategies:

• Establish the local communication plan

• Be the main link to the local monitoring team in the management of studies

• Collaborate with Vendor Functional Line Managers (FLM) to drive quality and study KPIs

• Plan / participate in study site engagement activities (i.e. Recruitment Booster calls)

• Work closely and proactively with MDAs/SEMs early on to drive the country strategy

• Coordinate local study team meeting at country or cluster level as applicable

• Establish regular exchange with GBU Medical Affairs regarding trail conduct and medico-marketing activities, e.g. publications, congress symposia

• Align on joint KOL/investigator management

Maintain Quality and Compliance through vendor oversight of all project deliverables according to project timelines and KPIs.:

• Responsible for data quality, patients’ safety and maintain compliance to study metrics.

• Identify potential problems (risks) and ensure proper mitigation plans are in place (recruitment, study conduct/data quality…)

• Ensure high quality for data collection and queries resolution at the country level, (prepares/reviews site enrollment cap increase request; Reviews and follows CAPAs raised through RBM alerts and deviation/issues re