tranScrip is a leading contract drug development organisation which supports the development and lifecycle of medicines. We offer a flexible working environment and opportunities for considerable reward and continuing professional development.

This is an exciting opportunity to lead various client projects & programs spanning across development and life-cycle activities for biopharmaceutical products. May include clinical trial management and/or medical writing activities.

The Senior Clinical Project & Program Manager is a senior member within the Project Delivery team and is responsible for the following:

For projects assigned:

  • Works closely with the Project Director to ensure clients expectations are met/exceeded for each client project. May act as Project Director for some projects/programs,
  • 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.

Non-project responsibilities:

  • 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.
  • Excellent interpersonal skills, able to encourage motivated teams and build client confidence in the team,
  • 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,
  • Excellent analytical/strategic skills.

Advantageous:

  • Has spoken externally on the topic of clinical operations/operational excellence,
  • 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.
  • Life science degree (BSc).
  • 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.

tranScrip offers a competitive reward package, which includes:

  • Permanent contract of employment,
  • Competitive base salary,
  • Bonus scheme,
  • Pension scheme,
  • Private health insurance and travel insurance,
  • Strong focus on CPD,
  • Career progression in a rapidly expanding organisation.
  • Office-based/home-based depending on candidate. If home-based must be able to work from the Winnersh office as requested (e.g., for client meetings, training, company meetings).

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

We have a rigorous assessment procedure in place to ensure applications are on target.
We respectfully ask for no recruitment agencies please.