Mapp Biopharmaceutical
  • San Diego, CA, USA
  • Full Time

CLINICAL PROJECT MANAGER

Job #02-17A

Mapp Biopharmaceutical is a small biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases. The Clinical Project Manager will be responsible for assuring the Clinical Research Organizations (CRO) and vendors are progressing the contracted work according to plan (scope, timeline, budget) and that all clinical scope project deliverables are being satisfied for the Mapp clinical programs.  

 Basic Qualifications:

  • Bachelor's and/or Master's degree in a scientific discipline, RN, BSN degree or equivalent scientific discipline
  • 5+ cumulative years clinical research experience is required
  • 2+ years experience as a Clinical Project Manager in a Drug Development organization is required
  • Willing and capable to manage multiple projects, timelines and responsibilities
  • Ability to balance scientific priorities with business priorities
  • Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment
  • Understanding of FDA, GCP, ICH and/or and other regulatory requirements that may impact global clinical studies and clinical trial management
  • Ability to engage in domestic and international travel to the degree appropriate to support the business of the team
  • Proficiency with MS Project for development and update of clinical study timelines
  • Proficient computer skills, specifically with Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook)
  • Conscientious, influential person with an outstanding work ethic and strong personal discipline
  • Strong communication, interpersonal, teamwork, organizational, problem-solving and negotiation skills
  • Excellent written and verbal communication skills

 Preferred Qualifications:

  • Experience supporting government contracts is an asset
  • Project Management Professional (PMP) Certification is an asset
  • Experience in assisting in global clinical studies a plus

 Responsibilities

  • Establishes and manages all Project Management tools and capabilities associated with scope, timeline, budget monitoring, risk and reporting for the Clinical program
  • Responsible for assuring all biweekly, monthly, and annual reporting deliverables are met
  • Responsible for assuring the Clinical Research Organization is meeting all Project Management and reporting deliverables
  • Provide Clinical PM support for future clinical planning and feasibility exercises
  • Provides Clinical PM support for contract proposal writing and vendor solicitations
  • Assists the facilitation of internal clinical/study team meetings through agendas, meeting minutes and action item tracking
  • Assists with maintenance of Trial Master Files 
  • Reviews invoices from study vendors, investigators, consultants, to assure consistency with effort executed
  • Proactively identifies and resolves issues, and participates in process improvement initiatives as required
  • Provides assistance with tracking versions, writing and/or editing study-related documents, including study protocols, informed consent documents, study manuals and plans, trial master files, case report form design, etc as needed
  • Contributes to the design, use and maintenance of core project management tools, processes and templates as part of the Mapp Project Management organization

Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will enjoy a flexible, collaborative and rewarding environment in San Diego, CA or may have the opportunitiy to work remotely. Mapp wants you to join their team and invites you to apply.

 No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.

 Equal Opportunity Employer - Applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.

Mapp Biopharmaceutical
  • Apply Now

    with our quick 3 minute Application!

  • * Fields Are Required

    What is your full name?

    How can we contact you?

    By clicking the button above, I agree to ApplicantPro's Applicant Information Use Policy.

  • Share this Page
  • Facebook Twitter LinkedIn Email
.
Logo Press Inquiries Services Product Development ZMapp News About Us Expanded Access Contact Us