Senior Clinical Study Manager (Early Phase Studies) required for Global Pharma, 12 month hybrid role (London) Inscope

Role responsible for:

Overseeing and managing clinical trial(s) which may involve directly managing a clinical trial(s) and/or providing support to members of the Clinical Operations team for the conduct of clinical trial(s) when allocated by the Head of Clinical Operations.

Where required, managing the internal/external study team members and ensures, that the timeline, budget, quality and integrity of clinical trial(s) is consistent with the clinical study protocol(s) and other study requirements.

Effective communication internally and externally of all study issues and actions related to the successful completion of the clinical trial(s).

Accountability

Establishes scope of work, timeline and expectation for SPs/ Contractors, develop and maintain contracts with SPs/Contractors.

Provides input to study documents, including study protocol, statistical analysis plan, clinical study report, audit plan, and/or author relevant sections of study documents.

Establishes, monitors and manages the study timeline and study budget.

Operation and Improvement

Sets up, implements and reports clinical trial(s), working with the project team and external Service Providers (SPs)/Contractors.

Monitors and reports the study progress and quality, analyzing potential issues and risks, and escalating / resolving them as appropriate.

Authorises, develops, reviews and maintains study documents with internal and external project teams and takes a lead role/contributes to development and maintenance of company policies, SOPs

Keeps abreast of the broad context of the industry related to commercial operations, regulations, best practices, relevant technologies and innovations.

Understands the implications for the assigned area and implements innovative operations approaches to help ensure efficient operations and achieve mandate.

Oversees the internal study team to meet the project plan.

Where required, manages SPs/Contractors and oversees their performance and quality of work to ensure they meet the project plan, contracts and any study specific requirements.

Organises and chairs the monthly project meeting(s) and ensures learning and knowledge transfer during and at the completion of the clinical trial(s), organising study meetings / training as required.

Conducts oneself at all times in accordance with working practices and ICH GCP.

Ensures appropriate recruitment strategy and plans are in place and adhered to.

Acts as the primary contact for all study operational management related communications with Service Providers (SPs) /Contractors and Development HQ.

Acts as the point of contact for managing/answering questions related to trial procedures and patients' eligibility.

What you need

B.Sc. in life sciences, nursing degree, or equivalent combination of education and experience.

Significant clinical research experience gained within a contract research organisation (CRO), pharmaceutical, or Biotechnology Company, with experience of technical and/or project management in conducting multinational and/or single site early phase clinical trials in a pharmaceutical company or CRO.

Thorough knowledge of regulatory requirements, clinical development, and clinical monitoring procedures.

Experience of leading project/study teams.

Proficiency with ICH/GCP guidelines.

Flexibility and the ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment.

Able to interact effectively at all levels within the organization, as well as with external partners and clients. Good negotiation skills. Strong written and spoken English. Excellent communication skills (verbal and written).

Excellent organisational, presentation and time management skills.

Excellent computer skills in Word, Excel, PowerPoint, email and Internet.

Please send your CV to Claire.helliwell@hays.com to discuss further