Associate Director Clinical Operations 8/27/2016
JOB DESCRIPTIONAPPLY Lead 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.
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, UR, IND.
Lead the study team kick-off meetings and subsequent team meetings (alone or with CRO and/or ARO meetings). Work with the Medical Lead to create the MB Charter, and take accountability for MB (or adjudication committee) meeting management. Take responsibility to ensure meeting logistics, agenda and minutes are in accordance with company 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 a_nd contingency measures are prepared and implemented. Actively assess potential risks to the study and propose mitigation plans._
_ _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.
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.
A Bachelors degree in the Sciences is acceptable.
Candidates with a nursing diploma/assoc degree with substantial experience may be considered for this position.
Must have Oncology Phase II/III experience.
Must have experience with CROs!