Clinical Research Manager II

Plans and manages clinical operations for assigned clinical project(s) including timelines, budgets, personnel resources, investigational sites, vendors and key project deliverables; manages, mentors and provides professional development guidance to assigned clinical operations staff members.DUTIES & RESPONSIBILITIESProvides strategic planning expertise, drafts the operations components, and ensures operational feasibility of clinical development plans and scenarios, including budget and resource estimates.

Manages the preparation of clinical sections of IND submissions, IND annual reports, investigator brochure updates, BLA/NDA submissions, NDA annual updates and clinical study reports.

Convenes and leads cross-functional clinical teams.

Coordinates and drives completion of the protocol concept, final protocol and template informed consent form.

Develops outsourcing specifications for vendor requests for proposal and scope of work agreements; participates in and guides study team in vendor selection and management throughout the life of assigned clinical project(s).

Works with study team(s) to determine patient recruitment strategies and operational feasibility and implementation of study objectives.

Authors and refines Clinical Operations Plans and study monitoring plans.

Leads ongoing study team review of data.

Manages and communicates to senior management overall clinical strategic operations plan for projects including timelines, internal and external resources/costs, key deliverables and key data issues.

Plans, convenes, runs and presents at investigator meetings.

Drafts study site agreements and budgets.

Develops and manages study timelines.

Identifies and provides solutions and direction related to key cross-functional, sponsor-site, and sponsor-CRO clinical trial issues.QUALIFICATIONSSasic qualifications:

BA/BS/RN/RPh (preferably in healthcare/science field) with 5+ years of progressive experience in clinical operations including site management and site monitoring.

Preferred qualifications:

Thorough understanding of FDA, ICH, and GCP guidelines as well as a thorough understanding of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, and regulatory affairs

Ability to lead a cross-functional team in a matrix environment

Excellent interpersonal and negotiation skills

Strong verbal and written communications and presentation skills

Proven problem solving and decision making skills

Strong leadership, planning and project management skills

Ability and willingness to travel 25% of the time (international and domestic)