Clinical Operations Manager/Associate Director/Director of Clinical Operations

San Carlos, CA 94070

Posted: 11/15/2019 Employment Type: Contract-to-Hire Industry: Clinical & Scientific Job Number: 16758

Job Description


Clinical Operations Manager/Associate Director/Director of Clinical Operations

 

 

Clinical Operations Manager will manage under the guidance of the acting CMO and VP of R&D all aspects of the clinical trial set up and conduct including preparation of the required documents, selection and auditing of the study sites, working with the CMC team to ensure timely preparation of the drug packaging and drug delivery, study start-up, enrollment, study conduct and close-out. The candidate must be knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines. The position will report to the VP of R&D. Strong preference for candidates with experience in setting up clinical operations and running clinical trials in critical care setting, especially acute stroke. Additional experience in oncology is a plus.

Responsibilities include but are not limited to:
  • Coordinates preparation and supports drafting of the clinical documents for the IND filing and start of the clinical trials.
  • Leads CRO selection process and day-to-day managing of the clinical CRO for the management of the clinical trials.
  • Works with acting CMO and VP R&D on selection and performs audits of the study sites.
  • Coordinates with CRO and is responsible for the execution of the contracting process, study site set-up, obtaining of the IRB approvals and other associated activities.
  • Coordinates with CMC team preparation of the drug packaging and timely drug delivery to the clinical sites and maintenance of the drug inventory at the sites.
  • Oversees all operational aspects of clinical trial(s).
  • Oversees clinical trial conduct including study start-up, enrollment, study conduct and close-out.
  • Prepares and reviews study-related and essential clinical study start-up documents (e.g., Clinical protocols, Informed consent forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters).
  • Participates in study strategy development, Line Listing Review, and Clinical Study Report preparation, as appropriate.
  • Manages the study project plan, including timelines and budget.
  • Provides training and manages CRO vendors such as IVRS, Central lab, Imaging.
  • Works with CRO to develop and revise study specific plans and detailed timelines, and ensure that transferred obligations and performance expectations are met.
  • Further manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project master files). Creates and implements corrective action plan when performance expectations are not being met.
  • Proactively identifies potential study issues/risks and recommends/implements solutions.
  • Participates in the selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function. Prepares metrics and updates for management, as assigned.
  • Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings.
  • Reviews site study documents (informed consent template and study tools/worksheets).
  • Serves as a liaison and resource for investigational sites.
  • Leads the development, review and implementation of departmental SOPs and processes.
  • Attends cross-functional meetings as needed to represent Clinical Operations and study-specific issues.
  • Provides mentorship and career development to direct reports.
  • Other duties as assigned.

Requirements:
  • At minimum, a bachelor’ s degree in nursing, science or health related field required.
  • At least 5 years of related oncology clinical trial management experience on the sponsor side.
  • Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology as well as thorough knowledge and understanding of GCP regulations.
  • Proficient in developing trial plans including site monitoring plans, risk mitigation strategies, site selection, and clinical supplies management.
  • Highly developed leadership skills to successfully lead a clinical study team,
  • Must be willing to travel at least 25% (possibly more).
  • Remote role may be considered.
  • Ability to deal with time demands, incomplete information or unexpected events.
  • Must display strong analytical and problem-solving skills.
  • Attention to detail required.
  • Outstanding organizational skills with the ability to multi-task and prioritize.
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
  • Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.

Title dependent on the level of experience

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Felicia Id-Deen

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