Clinical Project Manager

Location
Salary: £ 125000 to £999999
Contact name: Selina Maini

Contact email: selina.maini@medella.life
Job ref: 214
Published: 22 days ago

The Company

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

The Role

This position 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 the company’s and through a variety of vendors.


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:
  • Participate in discussions on the strategy for operationalization of clinical studies and site selection
  • Review and approve study plans and system set-up and ensure CRO and vendor compliance
  • Ensure appropriate training of team members (including CRO and vendor staff)
  • ICF development, review and approval
  • Collaborate on the development, review and approval of per subject budget and CTA and oversee CDA and CTA processes
  • Regulatory packet review, approval coordination and site activation
  • Monitor/co-monitor clinical trial sites and address operational issues
  • Review and comment on monitoring reports
  • Monitor applicable safety alerts and follow-up with MM, 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 EDC, CRFs and CRF guidelines
  • Participate and approve UAT of study systems as necessary
  • 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, IP shipments and study related problems
  • Participate in review of protocols, CSR, IB and other clinical or regulatory documents
  • Participate in the selection process for CROs and other vendors as applicable
  • Review clinical SOPs as needed
  • Represent the company’s at selected conferences and other meetings
  • 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
  • Strong background in conducting and monitoring clinical trials and pharmaceutical industry drug development process

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:

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

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