Manager Offre Microsoft F/H

JR France; Cannes; Sur place; EUR 50 000 - 70 000; Plein temps

Résumé du poste

A leading company is seeking a Site Start-up Manager to oversee daily operations and ensure quality standards in clinical research. The ideal candidate will have over 6 years of experience, proven leadership skills, and expertise in regulatory compliance. This role involves mentoring staff, managing resources, and contributing to strategic planning within a dynamic team environment.

Qualifications

• Minimum 6 years in clinical research with extensive Site Start-up experience.
• Knowledge of GCP/ICH guidelines.
• Fluency in English.

Responsabilités

• Manage day-to-day activities of Site Start-up personnel.
• Ensure compliance with SOPs and quality standards.
• Conduct performance reviews and facilitate career development.

Connaissances

Leadership

Strategic thinking

People management

Communication

Organizational skills

Formation

Bachelor's degree in life sciences or related field

Outils

Microsoft Office

CTMS

eTMF

EDC

Description du poste

Job Description:

Position Summary: Manages and oversees the day-to-day activities of Site Start-up (SSU) personnel in accordance with Standard Operating Procedures (SOPs), regulatory directives, and study-specific plans. Focuses on effective resourcing and personnel development. Provides oversight and leadership for site start-up project delivery; coordinates inter-departmental and client communication; and helps resolve administrative, personnel, and project issues.

Essential Functions:

1. Develop, mentor, manage, and coach SSU personnel to ensure quality standards are maintained.
2. Advocate for individual career development and responsibility.
3. Maintain routine 1:1 meetings with SSU personnel to manage tasks and career growth.
4. Serve as SME support for Site Start-up activities.
5. Ensure SSU personnel work to high quality standards and comply with SOPs, guidelines, project plans, and regulatory requirements.
6. Ensure proper resources, training, and access for SSU personnel.
7. Contribute to training plan development and accountability.
8. Ensure compliance with administrative tasks such as time entry, billing, and expenses.
9. Participate in interviewing and onboarding of new SSU personnel.
10. Develop standards and processes for staff and ensure consistent execution.
11. Manage FTE allocation per project, ensuring alignment with budgets.
12. Provide ongoing feedback, coaching, and conduct performance reviews.
13. Lead department meetings for high-level communication.
14. Support internal initiatives as needed.
15. Perform other duties as assigned.

Qualifications:

• Bachelor's degree in life sciences or related field, or equivalent experience.
• Minimum 6 years in clinical research, with extensive Site Start-up experience.
• Leadership experience or proven competencies.
• Knowledge of GCP/ICH guidelines and clinical development.
• People management skills and resource management experience.
• Proficiency in Microsoft Office and clinical software (CTMS, eTMF, EDC, etc.).
• Strong communication, organizational, and interpersonal skills.
• Experience in strategic planning, risk, and change management.
• Fluency in English.

Preferred:

• Advanced degree in life sciences or related field.
• Experience in CRO environment.

Competencies:

• Leadership and team inspiration.
• Strategic thinking and business acumen.
• Effective presentation and communication skills.
• High integrity and professional standards.
• Ability to influence, negotiate, and manage conflicts.
• Excellent time management and critical thinking.
• Occasional travel may be required.

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