Clinical Contracts Specialist
Job Opportunity at Spark Therapeutics, Inc

Posted on May 15

http://www.sparktx.com    215-220-9300

Location: Philadelphia, PA
Job Type: Full Time
Job ID: W4152822

The Senior Clinical Contracts Coordinator is responsible for providing support to the clinical operations group by coordinating the approval process for various clinical trial documents across all studies.  S/he will assist the clinical project managers and other members of the team to facilitate timely approval of documents.

  • Work across all studies and therapeutic areas to support clinical study teams.
  • Work with Spark legal to identify acceptable alternative/fallback language for clinical trial agreements and relative sections of the subject informed consent form (ICF).  Maintain tracker of accepted alternate language.
  • Streamline clinical trial agreement negotiation between investigative sites and Spark.  Escalate out of scope language to Spark Legal.
  • Work with study teams to develop clinical trial investigator budgets and acceptable overage windows.  Work with Compliance to ensure budgets are aligned with fair market values
  • Manage budget negotiations with investigator sites.  Escalate out of window site requests to the study team for resolution.
  • Function as the Clinical Operations point person for ICF review and Spark approval to changes from template language.  Escalate out of scope language to Spark Legal.
  • Reduce the volume of documents that need to go to Legal for review.
  • Track status of clinical trial agreements, clinical trial investigator budgets, and ICF ethics committee approvals across multiple clinical studies.
  • Manage changes to contracts/budgets and ICFs throughout the lifecycle of multiple clinical studies.
  • Ensure final documents are filed, maintained and archived in the appropriate location.
  • Ensure compliance to Spark SOPs, procedures and regulatory requirements for required forms and documents.
  • Facilitate written and verbal clinical trial agreement/budget/ICF communication to internal program team/functions, CROS, vendors, site personnel, and consultants when appropriate.
  • Attend study team, development/strategy team and departmental meetings.
  • Participate in departmental initiatives as requested.
  • Other duties as assigned

  • Strong initiative and “can do” attitude; professional work ethic
  • Organized and efficient; excellent attention to detail
  • Strong verbal and written communication skills
  • Excellent people and customer service skills

  • Bachelor’s degree preferred; relevant experience also considered
  • Generally has 3-5 years of relevant work experience such as contracts management or budget coordination
  • Familiarity with the pharmaceutical industry, clinical research, and/or clinical trials is desirable
  • Proficient in Microsoft Office applications


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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