An exciting opportunity has arisen for a Senior Clinical Operations Manager to join tranScrip; a rapidly expanding contract drug development company based near Reading.
The role will consist of Project management and/or leadership of various client projects spanning across development and life-cycle activities for biopharmaceutical products. It may include clinical trial management and/or medical writing activities.
tranScrip is a friendly and professional company based in a busy business park, offering excellent benefits including competitive salary, pension scheme, private healthcare and training/development opportunities.
- Office-based or home-based depending on the candidate. If home-based, the candidate must be able to work from the Reading office as requested (e.g., for client meetings, training, company meetings).
- Full time
- Generous salary
The Senior Project/Clinical Operations Manager is a senior member of the project management team and is responsible for the following:
- Work closely with the Project Director 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.
- 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.
- 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 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.
- Life science degree (BSc)
- 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.
- 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.
You can apply directly online or by sending your CV with a short cover letter to firstname.lastname@example.org