As a member of the Clinical Operations Team, the Clinical Project Manager/Senior Clinical Project Manager designs, plans, implements and executes the overall direction of clinical projects from protocol development, selection and qualification of vendors/investigational sites, operationalization of study activities (startup through closeout) and finalization of clinical study reports. S/he will collaborate with cross functional teams to design and develop clinical study protocols, develop and manage clinical operational, project and study management plans while adhering to budget, scope and schedule requirements. S/he will develop study performance matrix and management plans. S/he will manage program and project activities including but not limited to: clinical monitoring, data management, statistical analysis, medical writing, safety monitoring and compliance to insure proper conduct and timely completion of all projects.
•Manage all clinical operational aspects of the clinical program including:
•Execute and manage all aspects of multi-center global clinical trials within designated program budgets and timelines;
•Develop (but not limited to) the following program-specific documentations:
•clinical development plan
•program timeline and budget
•risk management plan
•KOL/advocacy engagement plan
•publication and congress plan
•Develop (but not limited to) the following study-specific strategy tools and processes:
•investigator/site/country/patient recruitment plans
•request for proposal [RFP] process
•communication plans (including site and sponsor communication as well as site escalation)
•ongoing data review plans
•risk management plans
•study timeline and budget
•publication and congress plan
•performance and compliance metrics
•Develop and review (but are not limited to) the following study-specific operational forms and tools:
•clinical protocols and amendments
•informed consent templates
•site feasibility questionnaires
•case report forms [CRFs] and CRF guidelines
•data / integrated voice recognition system [IVRS] management plans
•Investigative site binders, pharmacy brochures, and regulatory binders
•serious adverse events [SAEs] forms
•statistical analysis plans and data monitoring committee charters
•clinical study reports
•Collaborate with Legal department and/or clinical research organizations [CROs] to ensure timely review of the confidential disclosure agreements [CDAs] and clinical trial agreements [CTAs];
•Support selected investigative sites for IRB/IEC submissions, regulatory document collection and review, and budget and contract negotiations in collaboration with Legal and CROs;
•Manage and resolve study conduct issues (including protocol deviations, data queries, SAEs/AEs, laboratory discrepancies, and archive reconciliation activities) as applicable;
•Plan, execute, and lead study-specific meetings (e.g., Study Management Team [SMT], investigator meetings, advisory committee, etc);
•Provide study-specific training and leadership to internal staff, CRO, sites, and other contract personnel;
•Prepare and present program debriefings, as required.
•At the discretion of the function head, perform periodic site monitoring and vendor audit activities in accordance with protocol, monitoring plan, and ICH-GCP guidelines including:
•Perform Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-out Visits according to applicable company standard operating procedures [SOPs], regulations, and requirements of ICH-GCP;
•Complete visit report and investigator correspondence documenting visit progress and issue identification and reconciliation;
•Appropriate and timely follow-up with investigative sites as needed to ensure the identified study conduct issues are resolved and reconciled.
•Participate in and lead departmental initiatives as requested.
•Knowledge of ICH-GCP and FDA regulatory requirements and competency
•Strong clinical study operational and management skills
•Experience with managing external vendors (CROs) in the conduct of a clinical study
•Familiarity with clinical trial systems and operational infrastructure (eg, CTMS, Veeva)
•Ability to approach assigned duties in a highly organized, detailed and accurate manner.
•Organized and efficient, excellent attention to detail
•Excellent oral/written communication, organizational, and problem solving skills.
•Ability to work cross-functionally with other departments involved in the conduct of a clinical study.
•Ability (experience preferred) to work with cross-cultural teams including personnel from global locations as required per project with a positive attitude.
•Microsoft Project, Office, PowerPoint and Excel proficiency.
•A minimum of 5-8 years of related clinical trial and site monitoring experience with the last 3-5 years of experience in Pharmaceutical, Biotech or CRO company.
•Experience in conducting clinical trials in rare diseases, gene therapy, hematology, ophthalmology or CNS (1-2 years of recent experience) preferred;
•Candidates must have proven track record for delivering multi-center global clinical projects within time, budget, and quality expectations.
•Bachelor’s degree in science or equivalent RN/BSN nursing degree is a must (other majors considered with relevant work experience), advanced degree strongly preferred.
WHO WE ARE:
Transforming Patient’s Lives.
Spark Therapeutics is a pioneering gene therapy leader transforming the lives of patients suffering from debilitating genetic diseases by developing one-time, life-altering treatments. We are embarking on our goal to deliver the first approved gene therapy product in the US for genetic blinding conditions and have a product pipeline addressing other unmet rare genetic diseases. We have an entrepreneurial culture and are looking for talented and passionate professionals who are committed and motivated to making a difference in the lives of our patients. If you share our passion for excellence and are looking for a dynamic work environment that fosters creativity, scientific innovation and team collaboration, you may be a great fit for our team.