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.
Project management and/or leadership of various client projects spanning across development and life-cycle activities for biopharmaceutical products. May include clinical trial management and/or medical writing activities.
The Clinical Project & Program Manager is a member of the Project Delivery team and is responsible for the following:
For projects assigned:
- Works closely with the Project Director (and Senior Clinical Project & Program Manager where applicable) 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,
- 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 support to other team members where required.
- A minimum of 5 years’ experience in the pharmaceutical/biotech industry, ideally with experience in a CRO environment,
- Has experience in the management of clinical trials,
- Has experience in proactively identifying 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,
- Medical writing experience or a willingness to develop writing capabilities,
- Experience of regulatory activities such as scientific advice, IND development, NDA submissions etc,
- 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 firstname.lastname@example.org