An exciting opportunity has arisen for a Senior Clinical Operations Manager to join tranScrip; a rapidly expanding contract drug development company based near Reading.

 

The role will consist of Project management and/or leadership of various client projects spanning across development and life-cycle activities for biopharmaceutical products. It may include clinical trial management and/or medical writing activities.

 

tranScrip is a friendly and professional company based in a busy business park, offering excellent benefits including competitive salary, pension scheme, private healthcare and training/development opportunities. 

  • Office-based or home-based depending on the candidate. If home-based, the candidate must be able to work from the Reading office as requested (e.g., for client meetings, training, company meetings).
  • Permanent
  • Full time
  • Generous salary

The Senior Project/Clinical Operations Manager is a senior member of the project management team and is responsible for the following:

  • Work closely with the Project Director to ensure clients expectations are met/exceeded for each client project.
  • Project planning and initiation: risk assessment, communication plans, RACI, project schedule, planned budget.
  • Ongoing project management: schedule and budget management; risk, issue and change management; coordinating client and internal project meetings; internal and external team communications; management of action and decision logs.
  • Project close out: project assessment and recommended outcomes (e.g., process improvement).
  • Maintains project management documentation and performs other duties as described in tranScrip’s Standard Operating Procedure (SOPs), Work Instructions (WI’s) and Internal Procedures (IPs).
  • Multiple projects may be managed in parallel. Involvement will be varied depending on the complexity of the project.
  • As a senior member of the team will provide leadership of the project team where required and is able to work autonomously.
  • Business development activities/lead identification.
  • Supports client pitches and scoping calls.
  • Supports client proposal development.
  • Manages project budget and ensures accuracy of client invoices.
  • Expected to identify initiatives, efficiencies, areas requiring improvement and may contribute such projects. Particularly in the clinical operations area.
  • Provide mentorship to junior team members.
  • A minimum of 7 years experience as Project, Program or Product Manager in the pharmaceutical/biotech industry, ideally with experience in a CRO environment.
  • Proven ability to manage clinical trials, from start-up to CSR, in multiple therapy areas and phases and including vendor selection and oversight (including CROs).
  • Proven ability to proactively identify and manage project risk with a focus on data quality and integrity.
  • Thorough working knowledge of ICH-GCP, GxP and other applicable regulations.
  • Life science degree (BSc)
  • Excellent analytical/strategic skills.
  • Flexible and willing to adapt, in a fast-changing environment.
  • Pro-active, excellent time management, project management & planning skills. 
  • Excellent interpersonal skills and team-working capabilities. Able to build relationship across, up and down the organisation and externally.
  • Able to work well under pressure.
  • Medical writing experience or a willingness to develop writing capabilities.
  • Experience of regulatory activities such as scientific advice, IND development, NDA submissions etc.
  • Line management experience. 
  • Higher degree (e.g., MSc, PhD).
  • Excellent level of IT literacy (Microsoft Office suite including MS Project).
  • Able to travel, if needed.

You can apply directly online or by sending your CV with a short cover letter to recruitment@transcrip-partners.com

We are unable to accept VISA applications for this role and all applicants for this job must be legally entitled to work in the UK.
We have a rigorous assessment procedure in place to ensure applications are on target.