Associate Director, Clinical Operations
|Job Title:||Associate Director, Clinical Operations|
|Contact Name:||Amy Ma|
|Job Published:||January 23, 2017 22:33|
The Associate Director, Clinical Operations will 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.
Validate the study implementation plan provided by the CRO through to study close out and CSR writing.
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.
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.
Responsible for management of CRO(s) performance to ensure adherence to scope of work within timelines and budget at an overall study level.
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.
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.
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