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Senior Clinical Operations Manager

Job Description

Overview

The Sr. Clinical Trial Operations Manager is responsible for the execution and coordination of all activities required in the planning, implementation, and management of clinical trials through all periods of trial conduct working closely with Program Management and Regulatory Affairs. All activities are conducted in accordance with the appropriate quality standards including ICH-GCP Guidelines, SOPs, applicable regulations, rules, and guidance. This role is in Seattle Washington. This position reports directly to the Director of Clinical Operations & Development.

Responsibilities

  • Oversees set-up, ongoing quality review, and final reconciliation of study documents including review of site regulatory documents/packages and source documentation for Sponsor oversight of CRO and site activities.
  • Verify that the study regulatory files are collected and inventoried and filed as per sponsor requirements. Oversight of Curevo CTA for maintaining and auditing Trial Master File.
  • Maintain audit readiness.
  • Assists in the preparation and follow-up of in-house and on-site quality audits, as well as regulatory authority inspections.
  • Develops requirements/specifications for outsourcing to vendors. Works with Program Management team for review of vendor proposals, contracts, and budgets for accuracy with respect to the clinical trial protocol and trial activities. Review vendor invoices for accuracy as needed.
  • Oversee clinical monitoring (site qualification, site initiation, interim monitoring, clinical trial closeout visits) and other vendor activities to confirm integrity, accuracy and accountability of trial activities, clinical and research lab data ensuring compliance with the protocol, study manuals, IRB, ICH Good Clinical Practices (GCP), CFR, FDA, and applicable regulations. Perform sponsor audits of investigative sites and vendors.
  • Coordinate with CRO and data management for data base cleaning, soft lock and final database lock and ensuring data timelines are met. Assist with guidance and review of tables, listings, and figures for interim analysis or final data output. Coordinate with biostatistics in the transfer of final data for statistical analysis and coordinate the review of statistical analysis plans by subject matter experts as assigned.
  • Coordinate with trial sample research assay laboratory vendor in set up, and timeline tracking for completion of assays and delivery of final QC'd data. Oversee and support the coordination and delivery of clinical trial specimens to analyzing laboratories according to trial protocol and study manual specifications and study timelines. Coordinate review and impact assessment of laboratory deviations on sample analysis.
  • Coordinate with CMC team for investigational product (IP) supply and any IP issues identified on site during clinical trial.
  • Communicates project status, issues/solutions, and risk mitigation plans to Clinical Operations Director, other leadership (as appropriate) and other team members.
  • Facilitates cross-functional study team communication and coordination with Program Management and Regulatory Affairs team members.
  • Coordinates with consultants as assigned for review and obtain advice on clinical, and laboratory questions. Compile clinical trial operations materials and updates for consultants, Scientific Advisory Board, and Curevo Board of Directors.
  • Facilitates Clinical Study Team meetings with internal cross-functional teams, collaborators, and vendors. Document meeting minutes as needed. Oversees that study information is disseminated to the appropriate parties.
  • Contributes to the development of abstracts, presentations, manuscripts, and other external forms of communication.


Job Requirements

Education

  • BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, and Pharmacy).
  • Master's degree in Life Sciences preferred.


Experience

  • Minimum of 7 years clinical trial experience in the pharmaceutical, biotech industry, clinical trial site, or CRO, with at least 5 of those years managing clinical trial activities as a trial manager; however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate's eligibility.
  • Have a proven record of successful execution of clinical trials.
  • Strong leadership and management skills to provide planning, coordination and direction to staff and ability to propose innovative solutions to challenges.
  • Thorough knowledge of FDA, CFR and ICH GCP requirements and other regulatory requirements.
  • Previous experience with database build and/or database management an asset.
  • Able to set up and track key metrics and motivate a study team throughout the project life cycle.
  • Experience in the set-up and management of third-party vendors, as well as study start up.
  • Experience with phase 1-3 clinical trials. Global trial experience a plus.


Knowledge, Competencies and Skills

  • Analytical with strong organizational skills and the ability to manage large volumes of information. Exceptional attention to detail.
  • Excellent interpersonal and communication skills.
  • Outcome driven; can thrive in a fast-paced environment with rapid change while effectively managing pressure in a professional manner.
  • Able to set up and track key metrics and motivate a study team throughout the project life cycle.
  • Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team.
  • Demonstrable knowledge of effective project planning, along with the flexibility to coordinate with in person and remote team and collaborators will ensure success within this position.
  • Proficiency with MS Office products Word, Excel, PowerPoint, Outlook) and other electronic systems (CTMS, EDC and eTMF). Experience with Smartsheets is desirable.
  • Ability to travel for site for audits, scientific conferences, vendor qualifications as required. Travel approx. 5%, will be sporadic and may be greater during start up or audit timeframes, and possible conferences, or other activities as assigned.
  • Flexibility in work hours as needed to accommodate international collaborators or significant meetings/events. Flexibility for some remote and in-person combination on a weekly basis.
  • Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities


About Curevo Vaccine

Curevo Vaccine is a clinical-stage biotech company pioneering the development of vaccines for unmet needs. Our overall goal is to bring a safer, well-tolerated, highly effective shingles vaccine to the market with a high-yield manufacturing process for rapid global availability.

Attention: Search Firms / 3rd Party Recruitment Agencies

The Talent Acquisition / HR team manages the recruiting for all positions at Curevo Vaccines. We will only accept resumes from a search agency/recruiter if we have a signed agreement in place and the Talent Acquisition / HR team has formally requested your help on a specific role. Unsolicited resumes sent to Curevo Vaccine will be considered property of Curevo Vaccine. Curevo Vaccine will not be responsible for any fees associated should we hire from unsolicited resumes.

Recruiters are requested not to contact or present candidates directly to our hiring managers or employees and doing so may jeopardize eligibility to work on future positions.

Senior Clinical Operations Manager

TSP
Seattle, WA
Full Time

Published on 08/05/2022

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