Clinical Project Lead

Based: Central London

(Hybrid working policy, 3 days p/week on-site)

Are you a Clinical Project Manager/Lead with experience working with clients to ensure studies are planned and implemented to the highest standards, in compliance with ICH-GCP guidelines, SOPs and all applicable regulatory guidelines?

Our client has an extensive global network of sites and they provide clinical trials to a range of sponsors across various Therapeutic areas, with a main focus on cardiovascular, haematology and oncology therapeutic areas. 

Note this is a permanent full-time position working directly for our client in Central London.

They operate a hybrid working policy and there is a requirement to be in the office 3 days p/week.

Key Responsibilities:

To lead global study management teams in implementation of clinical trials ensuring the studies are performed and conducted in compliance with ICH-GCP guidelines, SOPs and all applicable regulatory requirements for the allocated study.

Creates project, quality, operational and risk plans, metrics reports, to ensure the successful delivery of high-quality project services and deliverables

Creates and manages study budgets and resources and works closely with finance department to provide study finance oversight

Serve as primary escalation point for assigned projects and assess/mitigate risks and help plan timelines for deliverables

Collaborates with the operational team to lead the delivery of training of sites ensuring that study team members are fully trained to perform their duties in accordance with Company/Sponsor SOPs

Drives communication with sponsors, partners and key customers e.g., Steering Committees, Investigators, Study Nurses and National Lead Investigators as and when required

Oversees the negotiation and execution of contracts and management of vendors ensuring delivery against contracted scope of work for the allocated region

Oversees regulatory and ethical submission and compliance, with a focus on local markets (complying with all applicable laws and regulations of each country)

Other relevant duties as directed by management

Desired Skills and Experience:

Proven clinical trials project management and leadership experience

Life science or other relevant degree

Excellent organisational skills

Excellent presentation skills

Excellent supervisory skills

Excellent interpersonal skills

Some experience in CPMIII/Global Project Management role

Proven ability to develop and update working practices

Flexible and effective project management, communication and negotiation skills

Ideally experience overseeing outsourced CRO work

Ideally a strong understanding of cardiovascular disease and treatment

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