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