Associate Clinical Project Manager

Location
Salary: £ 92000 to £999999
Contact name: Selina Maini

Contact email: selina.maini@medella.life
Job ref: 213
Published: 22 days ago

The Company
My client is a biotech company who specialise in engineering regenerative medicine and are seeking an Associate Clinical Project Manager to join their dynamic team.

The Role

The Associate Clinical Project Manager is responsible for the successful planning, implementation and execution of contracted activities. Functionally responsible for all team members throughout the duration of each clinical trial. Assures clear client communication, process documentation, and compliance with Good Clinical Practices and procedures. Supports the department director in development of functional training, definition of standards and execution of department goals including process improvement.

Responsibilities:

  • Oversees Clinical Research Organization (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 study plans and system set-up and ensure CRO and vendor compliance
    • Ensure appropriate training of team members (including CRO and vendor staff)
    • Regulatory packet review, approval coordination and site activation activities
    • 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 (EDC), Case Report Forms (CRF) and CRF guidelines
    • Participate in User Acceptance Testing (UAT) of study systems as needed
    • Manage study budget for assigned study, including review and approval of invoices against contracts
    • Ensure that clinical studies are conducted in accordance with SOPs, GCPs, ICH guidelines, and all applicable regulations
    • Key interface and resource for investigators
  • Communicate directly with CRO, vendors and sites regarding project issues, including enrollment strategies, protocol deviations, IRB issues, Investigational Product shipments and study related problems
  • Participate in the selection process for CROs and other vendors as applicable
  • Collaborate with cross-functional departments in overall clinical study management Other duties, as assigned

Specific Skills

  • Excellent knowledge of ICH/GCP/FDA and other country specific regulations and guidelines for medical devices and/or pharmaceutical/biologic agents

General Skills

· 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

Requirements

  • At least 3 years clinical research experience
  • At least 2 years of CRA experience or equivalent preferred
  • Both sponsor (CRO oversight) and CRO experience highly preferred
  • Clinical background/experience preferred (e.g., nurse, NP, PA)
  • Ability to travel to clinical sites, up to 25% of the time
  • Position may require working holidays, weekends and or during peak times


Connect
If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.


Medella Life
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything