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.
Clinical site management and monitoring of various clinical studies being overseen by tranScrip. Project management support for various client projects spanning across development and life-cycle activities for biopharmaceutical products.
The Clinical Project & Program Manager - Clinical Site Manager is a member of the Project Delivery team and is responsible for the following:
For projects assigned:
- Performs site feasibility, assessment, qualification, initiation, activation, monitoring and close out activities for clinical studies overseen by tranScrip as required,
- 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,
- Manages clinical site activities such as (but not limited to) regular contact with the sites, ensuring completion accurate of enrolment logs, issue resolution, data query resolution, remote and onsite monitoring of clinical data, ensuring timely entry of eCRF data,
- May train and coordinate the activities of other CRA resources (depending on projects scale),
- 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,
- May be involved in study level coordination tasks such as vendor management and data reviews.
- 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,
- Phase I-III experience,
- Has solid experience in the start-up, management and close out of clinical study sites,
- 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.
- Medical writing experience or a willingness to develop writing capabilities,
- Experience of regulatory activities such as scientific advice, IND development, NDA submissions etc,
- Experience of Oncology or CNS,
- Biologics/ ATMP experience highly desirable,
- Heath authority GCP inspection experience,
- Second Europe languages.
- Life science degree (BSc),
- Higher degree (e.g., MSc, PhD).
- Highly methodical, organised with strong leadership skills,
- 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.
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,
- Retail discounts,
- Strong focus on CPD,
- Career progression in a rapidly expanding organisation.
- Willingness to travel to sites up to 50%,
- 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