Manager, Clinical Operations

Position Summary:
Manager Clinical Operations is accountable for the operational management and successful country execution of all phases of clinical trials within assigned therapeutic area(s) or specific role(s), including resource allocation, adherence to timelines and budget, compliance with relevant Standard Operating Procedures (SOPs), policies, Health Care Compliance (HCC) and local regulatory requirements.

The Manager Clinical Operations supports Country Head in shaping and managing local organizational structure to ensure its optimal efficiency and demonstrates effective issue management.
This individual is responsible for line management of Local Trial Managers (LTM), Site Managers (SM), Clinical Trial Assistants (CTA) and/or other GCO staff, as required.

Oversees staff performance, development, training, project assignments, workload distribution and supports issue resolution with direct reports.

Ensures alignment of local goals with organizational objectives.

Drives innovative solutions and process improvements for the assigned therapeutic area(s), country, and GCO/Global Development (GD) overall.

Principal Responsibilities:
1 Provide line management to direct reports including setting goals and objectives, performance evaluation and talent development.
2 Evaluate and forecast resource needs for assigned portfolio and/or other specific area of responsibility, as required and agreed with local GCO management accordingly.
3 Responsible for deployment of the One Delivery Model through collaboration and oversight of vendors.
4 Accountable for the acquisition of new talents and development of human resources.
5 Guide direct reports in issue resolution and communication with involved stakeholders.
6 Lead organizational changes and effectively communicate on priority shifts as required.
7 Review and approve expenses in compliance with the company policies.
8 Demonstrate leadership behaviours in alignment with J&J Leadership Imperatives.
9 Foster an environment that encourages sharing of ideas, information and best practices (internal and external to the organization).
10 Provide coaching and mentorship as needed, including conduct of accompanied site visits as appropriate.
11 Define, execute or support of long term strategy in alignment with GCO, GD and JJIM R&D strategies to position the local and global GCO organization for success.
12 Oversight of execution and monitoring of clinical trials through all phases (from feasibility to close-out) and ensuring inspection-readiness within assigned therapeutic area(s) and/or other area of responsibility, as required.
13 Accountable for ensuring relevant operational objectives are met in conformance to ICH-GCP, relevant SOPs and other procedural documents.
14 Accountable for appropriate and timely issue escalation and reporting (suspicion) of fraud, scientific/ethical misconduct and health care compliance breach.

Contribute to CAPA and issue resolution in accordance with required timelines.
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