ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY FOUNDATION:
The Alliance for Clinical Trials in Oncology Foundation (Foundation) is a nonprofit, tax-exempt foundation created to enhance and expand the ability of the Alliance for Clinical Trials in Oncology (Alliance) to conduct cancer clinical research and address important treatment questions through large-scale clinical trials. The Alliance conducts trials as part of the National Cancer Institute (NCI) Clinical Trials Network (NCTN). Through efforts of the Foundation in support of the Alliance, clinical trials and laboratory research are conducted to discover new or improved ways to prevent, treat and cure many types of cancer, including leukemia and lymphoma, and cancers of the breast, prostate, lung and GI tract, and help educate the medical community on methods of cancer diagnosis, treatment, and prevention.
The Program Manager is responsible for managing collaboration agreements and budgets between the Foundation and research collaborators, in support of Alliance NCTN studies. The Program Manager serves as a leader of Foundation related activities and works closely with colleagues from the areas of protocol/scientific development, project management, finance, agreements/contracts, regulatory, quality assurance, site management, statistics and data management, in a cross-functional and collaborative team environment to develop and implement clinical trials.
- Manage collaborations with pharmaceutical industry partners for the Alliance NCTN portfolio
- Negotiate confidentiality disclosure agreements with pharmaceutical collaborators in order to obtain confidential information to initiate further negotiation
- Develop agreement and/or budgets to sub-agreements with various study collaborators, in conjunction with relevant agreements personnel.
- Develop and negotiate, work scopes and related budgets that include, but are not limited to, costs for drug storage and distribution, correlative science sub-study work, additional per case reimbursements, and administrative support, confirming that budgets are within fair market value (FMV), including Alliance clinical trial budgets for studies designated for a New Drug Application (NDA) with the FDA
- Issue study funding letters to various institutions and organizations that receive funds from pharmaceutical collaborators through the Foundation, ensuring the payment schedule is consistent with grant agreement
- Review and approve invoices and receipts to ensure alignment with master budget, in conjunction with accounting department
- Ensure successful completion of all budget and agreement negotiations for studies in development, according to the National Cancer Institute’s Operational Efficiency Working Group (OEWG) timelines for study activation
- Assess project timelines, develop contingency plans to mitigate risks and resolve issues, in conjunction with cross functional Alliance teams and external stakeholders, in order to achieve parallel progress in study development and meet timeline requirements
- Plan, coordinate, communicate and oversees various study-specific and internal meetings and teleconferences to provide study updates, resolve problems strategically and analytically, and prioritize work tasks
- Review study agreements to ensure obligations contained within agreements are in alignment with the organization’s SOPs and acceptable to the various departments involved
- Inform various departments of obligations agreed to upon fully executed agreements with pharmaceutical collaborators
- Monitor study milestones and fulfillment of obligations according to executed agreements
- Submit concepts to pharmaceutical industry collaborators through various channels (including online portal submission websites) to secure company support, including funding, for concepts prior to submission to the NCI for review
- Foster a collaborative atmosphere and reliable partnerships between the Alliance and funding agencies, pharmaceutical collaborators and selected vendors
- Lead or participate in working groups to gain alignment amongst various departments within the Alliance for Alliance NCTN concepts and trials that have a registrational intent component
- Supervise program management staff assigned to Foundation NCTN projects
Qualifications and Education Requirements:
- Bachelor’s degree (minimum)
- At least 5 years of relevant work experience (healthcare or clinical research experience preferred)
- Demonstrated ability to work independently and in a team environment
- Excellent oral and written communication skills, and strong organizational abilities
- Must be authorized to work in the U.S.
The above statements are intended to describe the general nature and level of the work being performed by people assigned to this job. They are not an exhaustive list of all duties and responsibilities associated with it.