tranScrip is a leading contract drug development organisation which supports the development and lifecycle of medicines.
We bring innovative solutions to pharma and biotech companies global drug development needs. From translational medicine through to registration and post licencing, we deliver both strategic leadership and operational execution of development programmes, covering clinical, regulatory, drug safety, and commercial elements.
tranScrip aspires to be a destination organisation for passionate innovators, talented problem solvers and determined deliverers in the life sciences sector, providing challenging and rewarding careers for those with successful track records and those who aspire to achieve them.
Transparency, flexibility and continuing professional development are at the core of our operating model, complemented by opportunities for considerable reward.
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,
- Develop, manage, and track the trial budget and provide ongoing financial reporting and forecasting,
- 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.
- 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),
- 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 proactively identify and manage project risk with a focus on data quality and integrity,
- Must be able to work in a fast paced environment under pressure capable of completing multiple competing tasks and demands,
- Thorough working knowledge of ICH-GCP, GxP and other applicable regulations,
- Experience as a CRA/ Field Monitor >1 year,
- Phase I-III experience.
- 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,
- Oncology/ CNS experience,
- ATMP / biologics experience,
- Line management experience.
- Life science degree (BSc),
- Higher degree (e.g., MSc, PhD).
- Highly methodical and strong leadership skills,
- High drive for operational excellence,
- Excellent interpersonal skills, able to encourage motivated teams and build client confidence in the team,
- Excellent written and oral communication,
- 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,
- Excellent level of IT literacy (Microsoft Office suite including MS Project).
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.
- The position will be home-based, preferably in the UK. Occasional travel to the tranScrip’s offices may be required.
You can apply directly online or by sending your CV with a short cover letter to email@example.com