The Sr. Clinical Project Manager is responsible for leading and managing the cross functional study team and is accountable for the operational delivery of one or more clinical studies from study concept through clinical study report (CSR). S/he is responsible for developing clinical study timelines and budgets and leading operational planning, proactive risk management and execution of clinical studies according to time, cost and quality targets. S/he is responsible for oversight of all study activities and escalates issues when needed from study concept through finalization of clinical study reports. S/he will collaborate with cross functional teams to execute 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 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.
·Manage all clinical aspects of the clinical project including:
o Plan, execute and manage all aspects of multi-center global clinical trials in compliance with GCPs, SOPs, and within designated program budgets timelines and corporate goals;
o Lead the study team to manage risk mitigation strategies including (but not limited to):
Accountable for vendor oversight including (but not limited to):
- Identify study level risks
- Develop, maintain and implement risk mitigation and contingency plans
- Ensure key functional lines and senior management are informed of study level major risks and contingency/mitigation plans
- Monitor progress against study plan and develop and implement operations risk management plans across the project
- Determine study requirements, define specifications/scope of work, and initiate and lead the selection of vendors
- Manage financial aspects for clinical vendors
- Manage and oversee CRO and clinical vendor relationship and activities; implement plans for efficient and effective vendor oversight
o Lead the development, review and approval of all study documents including (but not limited to) the following study-specific strategy tools and processes:
- Study timeline and budget
- Risk management plans
- Investigator/site/country/patient recruitment plans
- Request for proposal [RFP] process for clinical vendors
- Vendor specifications, management plan and oversight
- Communication plans (including site and sponsor communication, vendor communication as well as site escalation)
- Ongoing data review plans
- Educational/training plans
- Performance and compliance metrics
o Lead or contribute to the development, review and approval (when appropriate) of all study documents and tools including (but not limited to):
- Clinical protocols and amendments
- Informed consent templates
- Site feasibility questionnaires
- Case report forms [CRFs] and CRF guidelines
- Trial master file plan
- Data / integrated voice recognition system [IVRS] management plans
- Pharmacy brochures, and regulatory binders
- Data monitoring committee charters
- Clinical study reports
o 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];
o Manage clinical program/study budgets in conjunction with function head and Finance;
o Represent clinical study team for study planning and maintenance activities with external vendors
o Support selected investigative sites for IRB/IEC submissions, regulatory document collection and review, and budget and contract negotiations in collaboration with Legal and CROs;
o Manage and resolve study conduct issues (including protocol deviations, data queries, SAEs/AEs, laboratory discrepancies, and archive reconciliation activities) as applicable;
o Plan, execute, and lead study-specific meetings (e.g., Study Management Team [SMT], investigator meetings, advisory committee, etc);
o Communicate clinical study performance
o Manage clinical study budget within agreed variance
o Provide study-specific training and leadership to internal staff, CRO, sites, and other contract personnel;
o Prepare and present project debriefings, as required.
·At the discretion of the function head, perform site oversight and vendor audit and oversight activities in accordance with protocol, monitoring plan, and ICHGCP guidelines including:
Perform Site Oversight Visits according to applicable company standard operating procedures [SOPs], regulations, and requirements of ICHGCP;
Complete visit report and investigator correspondence documenting visit progress and issue identification and reconciliation;
Ensure adequate 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.
·Contribute to SOP development
Education and Experience Requirements:
Typically, 7-10 years related global clinical trial conduct and operations experience with a minimum of 3-5 years of project management experience with increasing levels of responsibility and a thorough understanding of processes associated with project and study management, knowledge of GCP, site monitoring and clinical operations. Experience in operationalizing clinical trials in Rare Disease preferred (minimum of 1-2 years of recent experience). Demonstrated project management and leadership experience. Proven track record for delivering multi-center global clinical projects within time, budget, and quality expectations.
- ICH-GCP and FDA regulatory requirement understanding and competency.
- Strong clinical study management skills, including risk assessment and contingency planning.
- Ability to approach assigned duties in a highly organized, detailed and accurate manner.
- Ability to manage multiple priorities and work in a flexible, dynamic, and fast-paced environment.
- Ability to proactively identify, resolve and escalate issues
- Ability to lead and manage in a dynamic environment
- Excellent oral/written communication, organizational, problem solving and conflict resolution skills.
- Ability to lead cross-functional team
- 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.
- Willingness to travel as dictated by assigned project requirements (approximately 25%). International travel may be required.
- A minimum of a Bachelor’ s degree in a scientific discipline or equivalent RN/BSN nursing degree (other majors considered with relevant work experience); advanced degree preferred
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
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