Monitoring Services Oversight - West London, United Kingdom - Novartis

Novartis

Verified Company

West London, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

100,000+ That's how many patients participate in our clinical trials at any given time.

GCO is Novartis' powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments.

Every day, we are the link between science and medicine - imagine the impact you could have as MSOM #GCO

The MSOM will be the Primary contact for FSP and other monitoring services (vendors) to assure adequate quality of the services & performance in Novartis sponsored clinical trials.

You will oversee vendor monitoring performance targets per defined quality performance indicators, including site recruitment commitments, timely data entry and issue resolution KPIs.

Aligns with FSP and other vendor's managers on CRA and other vendor resource related allocation to trials and studies.

This role requires strong communication skills and ability to influence internal and external stakeholders in order to maximize quality and efficiency of external service providers.

Key Responsibilities:

You will ensure timely communication with vendors' line managers to ensure sponsor requirements are up to date sets up governance model
Develop resource needs/expectations strategy and align with vendor line management (CRAs and other vendor resources)
You will Collaborate with Clinical Research Associate (CRA) Manager and other internal stakeholders for country resource strategy to be best single point of contact/ primary interface FSP/other vendors
Oversee country trial site activation, enrolment, data flow and timeline commitments are delivered per established trial objectives
In collaboration with SSO Clinical Project Manager (CPM), supports recruitment strategies and site performance by ensuring high quality and compliance of monitoring activities
Collaborates with SSO CPM for monitoring trends that require targeted training and/or development of CRAs to deliver to trial and quality KPIs
Close collaboration and alignment with global/hub S&O and Vendor partnership and governance functions

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

Minimum requirements

What you will bring to the role:

Excellent Decision making capability and oversight
Excellent management capabilities with demonstrated capability to problem solve and mediate complex compliance issues.
Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMEA), local/National Health Authorities regulations and Novartis standards

Desired skills

Minimum 7 years' experience in clinical research planning/executing and/or monitoring clinical trials
Experience and evidence of team leadership capabilities
Understanding of all aspects of clinical drug development with particular emphasis on monitoring and trial execution
Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMEA), local/National Health Authorities regulations and Novartis standards
Ability to anticipate potential issues and take appropriate actions with or without supervision

Division
Global Drug Development

Business Unit

GCO GDD

Country
United Kingdom

Work Location
London-West

Company/Legal Entity
Novartis Pharmaceuticals UK Lt

Functional Area
Research & Development

Job Type
Full Time

Employment Type
Regular

Shift Work
No

Early Talent
No