Sr. Clinical Study Manager
- Employer
- Spark Therapeutics
- Location
- Philadelphia, Pennsylvania. Hybrid and remote options available for select opportunities.
- Salary
- Salary not provided
- Closing date
- May 5, 2022
View more
- Discipline
- Life Sciences, Biotechnology
- Job Type
- Manager
- Organization Type
- Biotech
Job Details
- 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):
- 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):
- 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
- 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
- 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
- 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.
Nearest Major Market: Philadelphia
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.
Company
At Spark Therapeutics, a fully integrated, commercial company committed to discovering, developing and delivering gene therapies, we challenge the inevitability of genetic diseases, including blindness, hemophilia, lysosomal storage disorders and neurodegenerative diseases.
Founded in March 2013 as a result of the technology and know-how accumulated over two decades at Children’s Hospital of Philadelphia (CHOP), our investigational therapies have the potential to provide long-lasting effects, dramatically and positively changing the lives of patients with conditions where no, or only palliative, therapies exist. Greater understanding of the human genome and genetic abnormalities have allowed our scientists to tailor investigational therapies to patients suffering from very specific genetic diseases. This approach holds great promise in developing effective treatments to a host of inherited diseases. Our initial focus is on treating orphan diseases.
Headquartered in dynamic Philadelphia, we are a diverse, experienced team united in our goal to break down barriers for people and families affected by genetic diseases. As our name suggests, our investigational, one-time therapies are designed to spark healthy biology, and deliver potentially life-altering transformation for people and families affected by genetic disease. Spark is a member of the Roche Group.
- Website
- http://sparktx.com/
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