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.

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.

• 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.

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,
• 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.