Senior Clinical Research AssociateAssociate Clinical Trial Manager
Viamet Pharmaceuticals
The qualified applicant will be responsible for monitoring study sites, co-monitoring with the CRO Clinical Research Associates and working with the Viamet Clinical Trial Managers on in-house or outsourced studies to ensure that all operational deliverables e.g., timeline, quality, productivity are met. Candidates must be willing to come in-house Durham Office when not traveling.
Duties and Responsibilities
Establish efficienteffective working relationships with internal team members, sites and vendors
Prioritize effectively and respond appropriately to urgent requests from the team or other internal staff
Perform or attend as a co-monitor site selection, initiation, interim monitoring or close-out visits in various therapeutic areas
Evaluate the quality and integrity of the study site andor vendor CRA as related to the proper conduct of the protocol and adherence to applicable regulations
Work with the team to manage start-up activities, including site contract and budget negotiations and collectionreview of all essential documents
Work with the team to developreview study plans and tools i.e., monitoring Plan, Study Procedures Manual, tracking logs, Informed Consents, eCRF completion guidelines, etc.
Maintain and track study metrics to ensure vendors are meeting agreed targets
Other duties as assigned by senior management e.g. Assist with Investigator Meetings
Required Skills
Candidate should be able to
Lead a virtual team across locations and cultures
Prioritize project tasks and direct the team accordingly
Negotiate and influence with diplomacy in order to achieve effective results
Proactively identify and solve problems by using a logical, systemic approach
Ability to take initiative and work independently
Excellent interpersonal, oral and written communication skills
Ability to be flexible and adapt to change in a fast paced, small company environment
Strong knowledge of pharmaceutical industry regulations, including FDA regulations, GCP and ICH guidelines
Knowledge and experience in specify disease preferable
Proficient with the Microsoft Office suite of products and strong computer skills
Confirm your E-mail: Send Email
All Jobs from Viamet Pharmaceuticals