Manage multi-site and single site clinical trials conducted by the Robertson Clinical and Translational Cell Therapy Program. Write clinical protocols, INDs, BLA documents, review regulatory reports, review data submitted to INDs. Conduct site training, facility audits and vendor audits as needed. Manage relationships with external sponsors, from the initial discussion of interest, to negotiations around budgets, contracts and scope of work, especially for projects in the GMP lab. Manage project tracking and program evaluation for externally-funded programs, Provide senior coordinative oversight to project management activities of the Program.
Clinical trials management: Manage multi-site and single site clinical trials. Negotiate site budgets and contracts, pre-screen clinical sites, write training documents and train processing labs, conduct Site Initiation Visits (SIVs), select and manage CRO in collection of regulatory documents, development of data base and CRFs, randomization schedules and modules. Coordinate with statistician to create randomization schedules and sampling plans. Manage statistician, Data safety Monitoring Board (DSMB), and data management services to create and review data reports. Write DSMB charter and select and train DSMB members.
Regulatory writing: write clinical protocols, INDs, BLA documents, review regulatory reports, review data submitted to INDs. Monitor status of ongoing trials and outcomes. Advise and assist principal investigator and other team members in the development of plans, time lines, and processes for clinical research studies; coordinate the ongoing analysis and modification of protocols; recommend amendments to study protocols as appropriate. Confer with site coordinators and physicians to explain protocol and to elicit compliance with regulations; assure adherence to Federal Drug Administration and protocol guidelines; identify potential problems and/or inconsistencies and take action as appropriate.
Audits: conduct site training, facility audits, vendor audits as needed; help manage and train staff for FDA announced and unannounced audits. Serve as audit coordinator once FDA inspectors arrive.
Logistics: Manage clinical supply chain for study sites. Oversee the process for selection and shipping of cord blood units from CCBB for remote sites for processing. Coordinate with the GMP manufacturing lab to ensure cell therapy products for clinical trials meet testing and release criteria according to protocol and sponsor expectations.
Business Development / Relationship management: Manage relationships with external sponsors, from the initial discussion of interest, to negotiations around budgets, contracts and scope of work, especially for projects in the GMP lab. Serve as point of contact for other Duke investigators interested in using the GMP laboratory shared resource facility. Review proposed protocols to determine if projects are a good fit for the facility and to estimate resources required for the proposed work.
Project tracking: Manage project tracking and program evaluation for externally-funded programs, specifically the Marcus and Robertson programs. Provide senior coordinative oversight to project management. Organize review meetings and conduct cross functional research team meetings as needed. Provide materials for update submissions to the sponsors.
Perform other related duties incidental to the work described herein. The above statements describe the general nature and level of work being performed by individuals assigned to this classification.
Ability to review and translate scientific data required
Demonstrated ability to operationally manage several projects concurrently
Attention to detail
Excellent people skills
Ability to work well under pressure
Excellent communication skills, both spoken and written. Experience communicating with senior executives in both a private and academic setting towards development of new therapeutics.
Experience with FDA submissions and audits
Both leadership and management experience required
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Education Work requires a bachelor’s degree plus a minimum of six years of experience in clinical trials and sponsor relationship management.
Experience None required beyond that described above.
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
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