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Clinical Project Manager

All Openings | Research Triangle Park, NC | Full Time

Job Description

Humacyte, Inc., a biotechnology pioneer, discovers, develops and delivers innovative, award winning human biotherapies.  We are currently developing multiple vascular tissue engineered therapies and expanding our business model.  With a broad pipeline of potential new therapy applications, we continue to build our organization and scientific teams.  We are looking for additional colleagues to continue to build our expanding team.

Candidates will be expected to work both independently and collaboratively as part of the Humacyte organization. Applicants must be highly self-motivated, with solid communication skills, and demonstrates the ability to work in a team environment and lead other professionals and peers.

Position Background:

The Clinical Project Manager assists in the planning and execution of clinical projects while adhering to budget, scope and schedule requirements. Responsible for the oversight of CROs in executing clinical trials from protocol design to the final clinical study report.  Executes high quality, integrated cross-functional plans for the project/clinical trial.  Coordinates the activities of functional groups that comprise the clinical team (both internal and external) including, but not limited to: clinical monitoring, data management, statistics, medical writing, medical monitoring, and safety to insure proper conduct and timely completion of all projects.  Applies best practices in the development, initiation, planning, execution, control and closing of projects.  May also interact with finance, research and development, marketing, manufacturing and regulatory departments as appropriate.  Will be responsible for coordinating efforts for the trial both within Humacyte and through a variety of vendors.

Primary Responsibilities:

  • Manage assigned clinical studies within designated budget and timeline

  • Manage CRO and other vendors and day-to-day activities associated with the conduct of assigned clinical studies.  This includes, but is not limited to, the following:
    • Review and approve study plans and system set-up to ensure CRO and vendor compliance
    • Ensure appropriate training of team members (including CRO and vendor staff)
    • Regulatory packet review, approval coordination and site activation
    • Monitor/co-monitor clinical trial sites and address operational issues
    • Monitor applicable safety alerts and follow-up with Medical Monitor, CRO and sites
    • Track subject metrics to ensure subject visits are occurring as expected
    • Coordinate review of data listing and preparation of interim/final clinical study analysis reports
    • Contribute to the design and development of Electronic Data Capture, Case Report Forms (CRF) and CRF guidelines
    • Responsible for design, development and reconciliation of laboratory services
    • Manage study budget including review and approval of invoices against contracts
    • Oversee IP distribution to investigative sites
    • Ensure that clinical studies are conducted in accordance with SOPs, GCPs, ICH guidelines, and all applicable regulations
    • Ensure that clinical studies are conducted in accordance with executed contracts
    • Key interface and resource for investigators (includes monitoring in the field as needed)
    • Communicate directly with CRO and vendors regarding project issues, including enrollment strategies, protocol deviations, IRB issues, Investigational Product shipments and study related problems
    • Participate in review of protocols, Clinical Study Reports, Investigator Brochure and other clinical or regulatory documents
    • Participate in the selection process for CROs and other vendors as applicable
    • Review clinical SOPs as needed
    • Represent Humacyte at selected conferences and other meetings
    • Collaborate with cross-functional departments in overall clinical study management
    • Other duties, as assigned

General Competencies:

  • Able to communicate effectively in English, both verbally and in writing
  • Possess a positive roll-up-the-sleeves attitude and optimistic outlook
  • Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
  • Excellent organizational and time management skills with ability to set own priorities in a timely manner
  • High degree of flexibility and adaptability
  • Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
  • Must be able to work as needed to meet tight deadlines and at peak periods
  • Self-motivated and organized critical thinker with solid interpersonal and business communication skills
  • Demonstrated ability to work in a cross functional team
  • Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
  • Always observe safety precautions and regulations in all areas where duties are performed. Responsible for reporting all safety hazards and potential unsafe working conditions
  • Represents the organization in a positive and professional manner
  • Reports to work on time and as scheduled

Special Competencies:

  • Excellent knowledge of ICH/GCP/FDA and other country specific regulations and guidelines for medical devices and/or pharmaceutical/biologic agents
  • Strong background in conducting and monitoring clinical trials and pharmaceutical industry drug development process

QUALIFICATIONS:

  • Bachelor’s degree in relevant discipline, preferred
  • Experience will be considered in lieu of education
  • 3-5 years of Clinical Research Associate (CRA) experience or equivalent (CCRA preferred)
  • Minimum 1 year experience as Assistant Clinical Project Manager
  • At least 5-8 years clinical research experience
  • Both sponsor and Clinical Research Organization (CRO) experience highly desirable
  • Clinical background/experience preferable (e.g., nurse, NP, PA)
  • Experience with regenerative medicine products, preferred

Perks:

  • Stock Options
  • 401k Plan with Matching
  • Medical, Vision and Dental Plans
  • Long Term/Short Term Disability
  • Life Insurance
  • 23 Days Paid Time Off (PTO)
  • 11 Paid Holidays
  • Paid Parental Leave Policies

**Please note, Humacyte does not provide sponsorship at this time.**