The Senior Clinical Study Manager is responsible for supporting the implementation of assigned clinical studies including through study start-up, enrollment, execution, and close-out. S/he will assist the Clinical Project Manager for assigned studies with day to day clinical trial execution and maintenance activities and will serve as a point of contact for investigative sites. S/he will have responsibility and oversight on the planning and execution of clinical activities related to the clinical vendors, clinical sites, and regions under his/her responsibility.
- General study management activities (in conjunction with study lead for assigned projects):
- Establish productive, interactive relationships with site personnel; act as primary contact for site personnel for study related questions/issues, and/or outside vendors and site monitors
- Collaborate with clinical team and vendors to (a) develop study-specific documents, (b) ensure accurate preparation and review of all regulatory and other study-specific documents, and (c) ensure appropriate tracking of all study documents and maintenance of internal files
- Oversee operational aspects of assigned clinical studies including (but not limited to):
o Collaborate with the clinical team and external vendors to draft, review and finalize study specific documents (e.g., Case Report Forms)
o Prepare, review and maintain study specific essential documents
o Support sites by assisting with IRB/IEC submissions, regulatory document collection and review, and budget and contract negotiations in collaboration with the study lead and Legal.
o Coordinate IRB correspondence and ensure all approvals are obtained o Manage study supplies and equipment
o Ensure vendors and site personnel have appropriate system access and are trained
o Assist in study-related training of site monitors and site personnel as requested
- Manage and resolve study conduct issues (e.g., protocol deviations, data queries, laboratory discrepancies) and inform team members and leadership (as appropriate) of potential issues/mitigation as applicable;
- Assist in clinical vendor management including (but not limited to):
o Collaborate with the Clinical Project Manager on the selection of vendors
o Manage financial aspects for assigned clinical vendors
o Manage and oversee CRO and assigned clinical vendor relationship and activities; implement plans for efficient and effective vendor oversight
- Oversee site monitoring quality and adherence to established processes and plans; review monitoring visit reports
- May participate in all types of study visits (pre-study, initiation, interim, and close-out)
- Conduct site visits as required, co-monitor (as necessary)
- Respond to clinical sites in a timely fashion and maintain appropriate documentation
- Work with study lead to ensure maintenance of TMF
- Assist in generating investigator grant payments
- Facilitate communication between department, other functions, investigative site personnel, and external vendors
- Participate in departmental, clinical study related meetings, and asset development/strategy team meetings, as appropriate
- Participate in departmental initiatives, as requested
- Contribute to SOP development
- Other duties as assigned
Education and Experience Requirements:
- A minimum of a Bachelor’ s degree in a scientific discipline or equivalent RN/BSN nursing degree (other majors considered with relevant work experience)
- Generally has 5+ years of clinical study management experience with a minimum of 2 years of demonstrated study management leadership experience with increasing levels of responsibility and a thorough understanding of processes associated with study management and site monitoring.
- Experience in the therapeutic area of interest to Spark (e.g., ophthalmology, hematology, immunology, neurology) is a plus
- Thorough knowledge of the pharmaceutical industry, clinical research/trials, GCP, ICH guidelines
- Proficient in Microsoft Office applications
Key Skills, Abilities, and Competencies:
- Strong initiative and “can do” attitude; professional work ethic
- Strong written and verbal communication skills
- Available to meet peak workload demands and critical timelines; organized and efficient
- Highly attentive to detail; able to deliver a high-quality work product
- ICH-GCP and FDA regulatory requirement understanding and competency.
- Able to understand and comply with Good Clinical Practices (GCPs) and internal SOPs
Complexity and Problem Solving:
- Able to manage multiple priorities and work in a flexible, dynamic, and fast-paced environment
- Able to represent the company to health and research professionals by interacting in a professional, respectful manner at all times
- Able to proactively identify and respond appropriately to issues and provide guidance or escalate appropriately
- Able to interact in a positive and professional manner with internal personnel (including other departments) and external colleagues and vendors
- Able to work independently or with minimal supervision, take initiative, and complete tasks to deadlines
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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We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.
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