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Sr. Clinical Study Manager

Date: Apr 3, 2021

Location: Philadelphia, PA, US

Company: Spark Therapeutics

Join the Spark Team

 

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.

 

We don’t follow footsteps. We create the path.

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.

 

Responsibilities:

 

95%

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 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

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

 

5% Other Duties assigned

 

 

Requirements: 

Education:
 A minimum of a Bachelor’ s degree in a scientific discipline or equivalent RN/BSN nursing
degree (other majors considered with relevant work experience)
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 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

 

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

 

 

 

 


Nearest Major Market: Philadelphia