Job Summary: We are currently seeking a Associate Director, Clinical Operations in Edison, NJ. This position leads the execution of global or local clinical studies, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director will take responsibility for the clinical operational strategy and overall delivery of the clinical study (i.e. Delivery Lead role) and will represent Clinical Operations on the study team. This position may require line management responsibility of Clinical Study Managers, who are primarily responsibility for the tactical execution of the study. In the absence of Clinical Study Manager, the Associate Director will be expected to take both strategic and tactical roles (refer to, Sr. CSM PDQ) in order to deliver the study. . Responsibilities: Study Planning, Budget and Execution Lead the study team to develop a cross-functional, integrated study plan to study start up (in-house), and create initial study budget. Review study feasibility assessments provided by the CRO(s), select the CRO and provide input into ARO selection. Validate the study implementation plan provided by the CRO through to study close out and CSR writing. Ensure the timing of the major study milestones and the associated budget meet the needs of the overall development plan agreed by the Integrated Project Team (IPT). Lead site selection and site qualification discussions with study team and CRO. Take responsibility for incorporating the operational delivery aspects and logistics into the protocol and lead document writing and review for the protocol and amendments. Additional medical writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND. Lead the study team kick-off meetings and subsequent team meetings (DS alone or with CRO and/or ARO meetings). Work with the Medical Lead to create the DSMB Charter, and take accountability for DSMB (or adjudication committee) meeting management. Take responsibility to ensure meeting logistics, agenda and minutes are in accordance with DS standards. Oversee the CRO and provide timely input to ensure that the study is executed according to the agreed project plan. Complete a study risk assessment and ensure mitigation and contingency measures are prepared and implemented. Actively assess potential risks to the study and propose mitigation plans. Take specific accountability to oversee the quality of interim analysis prior to data base lock (DBL) , liaise with CRO to ensure timely DBL is achieved, and ensure delivery of the CSR in close coordination with the Medical Writer or CRO. CRO and Quality Oversight: Responsible for management of CRO(s) performance to ensure adherence to scope of work within timelines and budget at an overall study level. Specifically, track major study milestones and monitor overall operational performance metrics through the life of the study. Identify issues early and propose solutions. Whenever possible, resolve issues that have been escalated or if warranted, take issues to the appropriate governance committee. Create the budget at study start up, and monitor the overall agreed budget against trial progress. Work closely with internal and external stakeholders to ensure team awareness of the CRO scope of work (to minimize unwarranted change orders) and budget, so both can be managed appropriately. Provide oversight of the CRO to ensure compliance with Daiichi Sankyo’s quality measures. Lead the creation of the Quality Oversight Plan (QOP) and ensure study team adherence to the QOP. Be aware of and be able to predict deviations, or potential non compliance concerns (at a protocol level, site level, study level) and rapidly resolve or escalate to appropriate Governance Committee. People Management This position may require the supervision of functional and/or direct reports. In addition to providing instruction, direction of daily activities in support of goals, the supervisor will conduct a performance evaluation against development goals and career path requirements for their direct reports. The supervisor should coach and guide their functional and/or direct reports in support of their development needs, and facilitate conflict resolution on their behalf. *Managerial Path positions would require at least 25% time allocation towards people management. Clinical Operations Management/General Design, update and implement appropriate innovative and best-in-class procedures and SOP’s related to clinical study development and execution, in collaboration with Quality Assurance. Collaborate with Quality Assurance, QC function and regulatory Operations to implement TMF quality standards. This position may require support to overseeing implementation of CAPA in relation to sponsor’s audit or regulatory inspection. Education/Experience A Bachelors degree in the Sciences is acceptable. Candidates with a nursing diploma/assoc degree with substantial experience may be considered for this position. 7 years relevant experience is required with a BS, 5 years with a MS/MPH, or 3 years with PharmD/PhD/MD Must have a minimum of 3 years clinical trial Oncology experience Must have Phase II and Phase III Global Clinical Trial experience Must have CRA experience. Experience working within a CRO is preferred. Experience considered relevant includes clinical or basic research in a Pharmaceutical company, Academic Research Organization (ARO) or Contract Research Organization (CRO). Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant. Demonstrates advanced knowledge of design and phases of clinical studies on a global scale, global regulatory issues, CRO operations, and compliance practices Effectively oversees, manages, and influences CROs, and builds strong relationships at the senior levels within the CRO organization Manages and leads, at a junior level, clinical projects as well as management of broader projects at a global level Supports and effectively multi-tasks different and complex assignments and responsibilities. Effectively negotiates and influences to solve high impact/scope problems. Understands, identifies, mitigates, and communicates risks at the study or program level. Effectively leads and influences within the matrix at the study level; manages functional or direct reports. Sound understanding of the concepts and applications of clinical research, medical terminology and other disciplines involved in drug development. Proficiency in computer applications such as Microsoft Word, Excel, and PowerPoint. Strong oral and written communication skills.
Phama Job Categories:
Research and Development