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Sr. Project Manager in San Francisco, CA at Vaco

Date Posted: 2/26/2019

Job Snapshot

Job Description

Our client in Foster City, CA is looking for a Sr. Project Manager to join their team on a 9+ month contract basis. The ideal candidate will have 7-10 years of experience in Project management.

Responsibilities:

  • Management of clinical trial projects including development of project timelines (utilizing Microsoft Project software), study budgets, and study plans. Reports project status to senior management.
  • Participate on product development core teams as the clinical representative.
  • Lead clinical sub-teams and report sub-team activities to core team.
  • Responsible for identifying and selecting investigators. Build relationships with clinical sites.
  • Work with business development to contract external sites, consultants, vendors, contract research organizations (CROs), etc.
  • Manage activities performed by consultants, CROs and vendors including initial identification of a suitable partner, definition of responsibilities, preparation of communication plan, defining division of responsibility, monitoring of milestones and budget, review of monthly status reports, and interactive management to ensure project success.
  • Write and/or review trial related documentation (protocols, case report forms, consent documents, letters of agreement, confidentiality agreements).
  • Submit protocols to IRB/EC, assist clinical testing laboratories with IRB/EC submissions, and ensure collection and review of required essential study documents and reports.
  • Ensure adequate monitoring of study is conducted by clinical sub-team.
  • Review, assess, and interpret data from ongoing and completed studies, and prepare reports as required.
  • Write and/or review clinical sections of regulatory submissions and product labeling and ensures compliance with applicable regulations.
  • Writes abstracts, papers, and manuscripts related to study results as required
  • Responsible for the oversight of the ongoing maintenance of the Trial Master File
  • Participate in the conduct of internal and external audits and inspections of clinical studies.
  • Monitor compliance with all company standard operating procedures (SOPs), GCP, FDA and applicable international regulations concerning clinical activities.
  • Compile, review and conclude device complaints. Ensures corrective action is taken, as needed.

Required Skills:

  • Excellent verbal and written communication skills. Excellent organizational, record retention, time management, decision making, customer service, and interpersonal skills. Good command of written and spoken English language.
  • Plans and makes decisions by considering impact from all relevant perspectives; able to verbalize decisions in a thorough and effective manner.
  • Able to proactively identify and address areas of inefficiency and provide creative, successful solutions. Holds self and others accountable for adherence to high work and ethical standards
  • Flexible; adapts work style in order to meet department and company needs.
  • Deals with broad, new issues with limited guidance or direction.
  • Develops solutions based on limited information and oversight.
  • Computer proficiency (MS Word, MS Excel, MS Project, and MS Visio) required.
  • Ability to travel domestically and internationally, as required (up to 25%).