Job description

LOCATION: CORK, IRELAND (relocation package available )

The Trial Capabilities Senior Manager leads the clinical trial capabilities in support of clinical development. The Senior Manager is accountable to ensure the investigator sites meet requirements to enrol study participants into clinical trials and support ongoing activities during site maintenance and close-out. This includes submission of documents to regulatory authorities and Ethics Review Boards, serve as the point of contact for a site’s ERB and Competent Authority (CA)(where applicable), assist in budget and contract negotiation. The senior manager is accountable for the prioritisation, planning and implementation of site initiation activities working closely with the site engagement at the affiliates, global study teams and the design hub ensuring accurate planning, prioritisation and timely execution to meet portfolio needs.

The senior manager provides leadership, direction and technical support to the Clinical Trial Capabilities Teams focusing on results and driving efficiency to achieve goals and objectives. The senior manager will ensure inspection readiness at all times through a complete, accurate and readily available Trial Master File.

Responsibilities:

Manage communications/relationships and serve as the point of contact for the trial capabilities deliverable during site initiation, maintenance, and close out representing progress to business partners.
Accountable for prioritisation of work to meet portfolio needs.
Ensure flexibility of resources across trial capabilities teams and geographies.
Provides expertise in conducting clinical research and keeping up to date with country/regional regulatory requirements.
Develop and manage strategies to improve customer experience.

Identify and ensure shared learning across the clinical capabilities organization and with other functional groups within the CDO and MDU.
Recruit, develop, and retain a scientific and operationally capable workforce skilled and knowledgeable in clinical development

Develop an organizational culture that fosters inclusion and innovation and demonstrates judgment based decision making in clinical delivery.

Minimum Qualification Requirements:

Bachelor’s degree preferably in a scientific or health related field, five years clinical research experience or relevant experience preferred.
Previous supervisory experience.

Job Types: Full-time, Permanent

Salary: Up to €75,000.00 per year

Schedule:

• 8 hour shift
• Monday to Friday

Supplemental pay types:

• Yearly bonus

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