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.

Leadership of the clinical project and program management team leading organisation and process ensuring operational excellence. Development and delivery of marketing materials and plan for clinical operations. Leadership of 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 Head of Clinical Project & Program Management is a senior member/manager within the Project Delivery team and is responsible for the following:

Management responsibilities:

  • Line management of the clinical project & program managers including coaching/development support,
  • Organisation of process to ensure operational excellence of delivery of clinical projects/programs,
  • Develops and delivers on the marketing plan and materials for clinical operations,
  • Supports and provides cover for the Head of Project Delivery as needed,

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,

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.
  • A minimum of 10 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,
  • 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). 
  • High drive for operational excellence,
  • Excellent interpersonal skills, able to encourage motivated teams and build client confidence in the team,
  • 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.