Under the direction of Director, Clinical Operations or designee the (Sr) Clinical Study Manager is accountable for the day to day operational activities related to planning, executing and reporting of assigned clinical study(ies) supporting the (Sr) Clinical Program Manager (CPM) and Medical Director leading the development program. The Sr CSM/CSM will independently organize and manage multiple activities related to clinical studies, while simultaneously ensuring study milestones are met and studies are completed in accordance with the protocol and ICH/GCP requirements. Future growth opportunities would include independently managing small studies of basic to moderate complexity or defined activities in more complex, multicenter studies (i.e., overseeing key vendor deliverables and activities; monitoring/co-monitoring clinical sites).
In collaboration with the operational project team members and stakeholders from Finance oversees clinical study vendor(s) to ensure compliance with the contracted study specifications (i.e.., timelines, deliverables) and applicable SOPs
Drives the conduct of the study, (tracks status, maintains study level reporting systems, oversees forecasts, progress, and mitigation plans), to ensure all study operational aspects are on track to maintain study timelines
Supports (Sr) CPM or designee in developing operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management.
Ensures recruitment targets are met and reviews enrolment at the site level including responsibility for coordinating the approval of enrolling above site targets with senior management.
Is responsible to coordinate contingency plan to ensure recruitment targets are achieved in accordance with trial execution plan
Ensures accurate, timely, and complete tracking of data entry, acquisition and sample transfers
Coordinates the study monitoring process with the CRAs and their managers to ensure proper documentation and filing of Essential Documents management
Supports inspection readiness and submission preparation for monitoring related activities and assists with internal audits and regulatory inspections, as required, and ensures implementation of corrective actions within specified timelines
Participates in multidisciplinary taskforces to support continuous improvement initiatives
Applies thorough knowledge of GCP/regulatory requirements to all aspects of the study
Manages all external and internal documentation for assigned trials ensuring it is completed in accordance with the study protocol, internal SOP’s and GCP requirements (e.g., Patient Informed Consent Forms, Monitoring Plans, Project Plans)
Support clinical site monitoring activities and co-monitors as needed
Support development of any may conducts training regarding the operational aspects of the clinical trial including protocol, lab manuals, etc. to both internal team members and clinical site staff
May represent Clinical Operations in cross-functional initiatives as (Sr) CPM designee
Develops and maintains effective working relationships with multiple teams, external CRO (for outsourced teams) and co-development partner study teams.
Oversees the development and maintenance of study specific manuals.
Contributes to the development and management of the study timelines, resources, budget, risk and quality plans.
Drives the development of protocol feasibility questionnaires either independently or in partnership with study team members.
Interaction with Clinical Sites
Directly and/or through guidance of Sr CPM or designee and in partnership with CRO CRAs
Attend to procedures to support sites (e.g. provide guidance on case report form [CRF] completion, study documentation)
Collect data/observations, and obtain study conduct feedback
Interact directly with clinical sites, including clinical investigators, study site coordinators and other health care professionals involved in the clinical study as may be necessary
Conduct site visits (e.g., site selection visits, pre-study site visits, training visits, site initiation visits, interim site visits, and study close-out visits) as may be required
Willing and able to travel 20 -30%
Displays project management skills related to study management with assistance from Senior Clinical Operations staff
Demonstrates ability to communicate and coordinate activities with the internal team, clinical sites and vendors
Able to proactively identify project challenges/risks and implement appropriate actions with some supervision
Strong communication (written and verbal) skills and clinical project management capabilities with demonstrated ability to problem solve and mediate complex issues
Demonstrated computer skills; proven functional knowledge of Microsoft packages and ability to develop proficiency in relevant Jounce systems and programs
Demonstrated negotiation and conflict resolution skills both internal and external (site relationships)
Thorough understanding of the drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMEA)
Experience in managing all trial components (start-up to database lock) preferred
Preferred experience in neuromuscular or dermatology studies