Clinical Research Manager Oncology

At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. _
- We have 40,000 people around the world who show up every day to achieve the unimaginable. This work requires heart, science, and ingenuity. We never stop imagining a future where the most challenging diseases are a thing of the past. _

We are looking for a **Clinical Research Manager Oncology (M/F) **/ functional manager I (FM I).

The **Functional Manager I (FM I)** is accountable for strategic and 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 FM I supports the Local R&D 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 (LTMs), Site Managers (SMs), Clinical Trial Assistants 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 Clinical Development Organization (GCDO) overall.

**PRINCIPAL RELATIONSHIPS**:

- **Primary Reporting Structure**: Reports to Director Functional Management or Local R&D Head.
- **Primary interfaces**: Local Trial managers, Site Managers, Clinical Trial Assistants, Local R&D Head, other Functional Managers, Global Product Lead/Global Trial Lead, Regional Therapeutic Area Lead and supporting roles in the country.
- **Other Internal Interfaces**: R&D/Local Operating Company staff (including Medical Affairs), departments within and outside of GCO/GCDO, i.e. Portfolio Delivery Operations, EBIS, IDAR, BRQC, HCC, External Alliances, Contracts & Grants and others as required.
- **External Interfaces**: Functional management of flex providers, Health Authorities, Ethics Committees, investigational sites, local vendors and others as required.

**PRINCIPAL RESPONSIBILITIES**:

- Provide line management to direct reports including setting goals and objectives, performance evaluation and talent development.
- Evaluate and forecast resource needs for assigned portfolio and/or other specific area of responsibility, as required and agreed with local GCO management accordingly.
- Support the flexible resourcing model and collaborate with flex resource managers to get qualified staff in a timely manner, provide feedback on flex staff performance and support their on-boarding and off-boarding.
- Interview, hire, develop and train staff.
- Ensure understanding of relevant processes and procedural documents supported by documentation of direct reports’ training compliance, as required.
- Support direct reports in issue resolution and communication with involved stakeholders
- Support local implementation of organizational changes and effectively communicate on priority shifts.
- Review and approve expenses in compliance with the company policies.
- Demonstrate leadership behaviours in alignment with J&J Leadership Imperatives
- Foster an environment that encourages sharing of ideas, information and best practices (internal and external to the organization).
- Provide coaching and mentorship as needed, including conduct of accompanied site visits as appropriate.
- Define, execute or support of long term strategy in alignment with GCO, GCDO and Janssen R&D strategies to position the local and global GCO organization for success.
- 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.
- Ensure relevant operational objectives are met in conformance to ICH-GCP, relevant SOPs and other procedural documents.
- 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.
- Shape and maintain strong relationships within local GCO department and Local Operating Company (particularly with Medical Aff