Clinical Research Manager

hace 1 mes

Madrid, España Johnson & Johnson A tiempo completo

Position Summary:

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 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. 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.

4. Interview, hire, develop and train staff.

5. Ensure understanding of relevant processes and procedural documents supported by documentation

of direct reports’ training compliance, as required.

6. Support direct reports in issue resolution and communication with involved stakeholders

7. Support local implementation of organizational changes and effectively communicate on priority shifts.

8. Review and approve expenses in compliance with the company policies.

9. Demonstrate leadership behaviour in alignment with J&J Leadership Imperatives

10. Foster an environment that encourages sharing of ideas, information and best practices

(internal and external to the organization).

11. Provide coaching and mentorship as needed, including conduct of accompanied site visits as

appropriate.

12. Define, execute or support of long term strategy in alignment with GCO, GD and Janssen R&D

strategies to position the local and global GCO organization for success.

13. Oversight of execution and monitoring of clinical trials through all phases ( from feasibility to closeout) and ensuring inspection-readiness within assigned therapeutic area(s) and/or other area of

responsibility, as required.

14. Ensure relevant operational objectives are met in conformance to ICH-GCP, relevant SOPs and

other procedural documents.

15. 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.

16. Shape and maintain strong relationships within local GCO department and Local Operating Company

(particularly with Medical Affairs) and other key internal and external stakeholders.

17. Develop country capabilities for an effective study placement within assigned therapeutic area(s) and/or

other area of responsibility, as required.

18. Accountable for robust feasibility process and oversight of site selection to deliver on country

commitments within assigned therapeutic area(s) and strategic goals.

19. Support regular metrics review and drive necessary follow-up actions.

20. Contribute to development, evaluation and implementation of new processes and systems to improve

study management.

21. Ensure adequate quality oversight within assigned therapeutic area(s) and/or other area of responsibility,

as required.

22. Foster a culture of continuous improvement and innovation within the local GCO team.

23. Model Credo based culture within the local GCO team

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/GD, 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.

Education and Experience Requirements:

Bachelor's degree or equivalent required, preferably in Life Sciences(e.g., Biology, Chemistry, Biochemistry,

Nursing, Pharmacy).

Minimum of 5 years of clinical research experience acquired in pharmaceutical industry, CRO or

investigational site.

Effective communication and leadership skills. Ability to foster team productivity and cohesiveness.

Experience in mentoring/coaching others (line management experience desirable). Skilled in leading,

hiring, training, developing and evaluating people. Solid decision-making and financial management

skills.

Effective issue resolution and ability to generate and implement contingency plans for both productivity and

quality issues when required. Excellent knowledge of drug development, clinical research operations and

regulatory requirements including ICH-GCP, HCC and applicable regulations. Ability to synthesize and evaluate

data generated from various reports and sources. Demonstrated skills in effective communication with various

internal and external stakeholders (e.g. investigational sites, ethics committees, health authorities, etc.).

Flexible mindset and ability to work in a fast-changing environment. Operates under limited supervision.

Proficient in English language. Computer literacy. Strong interpersonal and negotiating skills. Excellent

organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment.

Perform activities in a timely and accurate manner.

Travel:

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