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Clinical Operations Lead Hematology
Job Opportunity at
Spark Therapeutics, Inc
Posted on Jul 21
As a senior member of the Clinical Research and Development Team, the Clinical Operations Lead - Hematology is responsible for the overall management of the clinical programs for all Hematology projects, including the implementation, execution and completion of all departmental clinical trials and site selection and management. S/he will also assist (as needed) in development of new programs and departmental initiatives and participate in strategic planning activities throughout the organization. S/he will also be responsible for oversight of all hematology studies, designing, planning and implementing overall direction of clinical projects from protocol development, selection and qualification of external service providers/investigative sites through finalization of clinical study reports. S/he will manage the 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. S/he will be responsible for oversight and management of clinical operations project teams and personnel for the Hematology program, and will interact with the Hematology Asset and Brand Strategy teams.
Manage all clinical aspects of the Hematology clinical program including:
Plan, execute and manage all aspects of multi-center global clinical trials in compliance with GCPs, SOPs, and within designated program budgets and timelines
Design and develop (but not limited to) the following program-specific documentation:
clinical development plan; integrated project plan
program timeline and budget
risk management plan
KOL/advocacy engagement plan
publication and congress plan
Design and develop (but not limited to) the following study-specific strategy tools and processes:
investigator/site/country/patient recruitment plans
request for proposal RFP process
external service provider specifications
communication plans (including site and sponsor communication as well as site escalation)
ongoing data review plans
risk management plans
study timelines and budgets
publication and congress plans
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].
Create and manage clinical program/study budgets in conjunction with Project Management and Finance.
Represent clinical study team for study planning and maintenance activities with external service providers, and on internal product development teams.
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, external service providers, and other contract personnel.
Prepare and present program debriefings, as required.
Clinical Operations Functional Activities:
Manage/oversee clinical study activities, including clinical budgets and timelines; develop contingency plans for clinical trials.
Provide input to Clinical (or other) project teams as needed.
Support development of the Clinical R&D function: identify, implement, and manage departmental processes and systems (eg, eTMF,external service provider selection, SOPs, etc.).
Evaluate and select personnel; manage staffing needs to ensure the efficient operation of the function. Effectively mentor departmental personnel.
Assist in writing departmental as well as scientific technical documents.
Work cross-functionally to develop and implement strategic initiatives.
Participate in diligence and business development activities
Other duties or projects as assigned
Extensive knowledge of ICH-GCP and FDA regulatory requirements and competency.
Strong clinical study design and management skills, including risk assessment and contingency planning.
Knowledge of 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 leadership skills, oral/written communication, organizational, problem solving, conflict resolution, and team building skills. Ability to manage teams and develop personnel independently.
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.
Bachelor’s degree (minimum); advanced degree in a scientific discipline, or equivalent experience preferred.
A minimum of 10-12 years of related pharmaceutical/CRO clinical trial and site monitoring experience with increasing levels of responsibility.
Experience in operationalizing clinical trials in Rare Disease or hematology strongly preferred.
Must have proven track record for delivering multi-center global clinical projects within time, budget, and quality expectations.
Prior experience managing clinical operations function/personnel 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.
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