Post A Job
Jobs By Company
Keyword or Job ID
Sr. Clinical Contracts Specialist
Job Opportunity at
Spark Therapeutics, Inc
Posted on Jun 14
The Senior Clinical Contracts Specialist is responsible for providing support to the clinical operations group by leading the approval process for various clinical trial documents across all studies. S/he will lead the process of coordinating across clinical project managers and members of the legal team to facilitate timely approval of documents.
*This position offers a flexible onsite schedule
Work across all studies and therapeutic areas to support clinical study teams.
In close collaboration with Spark Legal, lead the process of identifying 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.
In close collaboration with the clinical study teams, lead the process of developing 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.
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 5+ years of relevant work experience such as contracts management or budget coordination
Strong working knowledge of clinical site agreements, vendor management, budgeting and negotiations
Strong understanding of best practices related to cGCPs, QA, informed consents and clinical study protocol management
Demonstrated ability to lead the clinical contracting process from template development through negotiation/finalization, and on-going document management
Proficient in Microsoft Office applications
WHO WE ARE:
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.
Terms of Usage
MedicalDeviceIndustryNow.com is owned, operated, and copyrighted by Career Marketplace (© 2002-2019, All Rights Reserved)