Manager Offre Microsoft F/H

JR France; Saint-Nazaire; Sur place; EUR 55 000 - 75 000; Plein temps

Résumé du poste

A leading company in the clinical research sector is seeking a Site Start-up Manager to oversee and lead the daily activities of the Site Start-up team. The role entails managing personnel development, ensuring adherence to regulatory guidelines, and effective project delivery. Candidates should have a background in life sciences, extensive experience in clinical research, and demonstrated leadership capabilities to foster a high-performance 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.
• Develop and mentor SSU personnel.
• Ensure compliance with SOPs and training goals.

Connaissances

Leadership

Communication

Organizational Skills

Attention to Detail

Strategic Planning

Risk Management

Negotiation Skills

Problem Solving

Formation

Bachelor's degree in life sciences or related field

Advanced degree in life sciences or related field

Outils

Microsoft Office

Clinical software (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, with an emphasis 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 include but are not limited to:

1. Develop, mentor, manage, and coach SSU personnel to ensure quality standards are maintained. Advocate for individual career development and responsibility.
2. Maintain routine 1:1 meetings with SSU personnel for task management and career development.
3. Serve as SME support for Site Start-up activities.
4. Ensure SSU personnel work to high quality standards and comply with SOPs, guidelines, project plans, and regulatory requirements.
5. Ensure proper resources, training, and access are provided to SSU personnel.
6. Contribute to training plan development and hold personnel accountable for training goals.
7. Ensure administrative tasks compliance, including time entry, billing, and expense reporting.
8. Participate in the interview process for new SSU personnel.
9. Support onboarding training for new personnel.
10. Develop standards and processes for staff and ensure consistent execution.
11. Participate in resource planning and manage FTE allocation per project.
12. Provide ongoing feedback, development, and coaching, including performance reviews.
13. Conduct department meetings for high-level communication.
14. Assist with internal initiatives and 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 process.
• Experience in people management, team environment, and resource management.
• Proficiency in Microsoft Office and clinical software (CTMS, eTMF, EDC).
• Strong communication, organizational skills, and attention to detail.
• Experience in strategic planning, risk, and change management.
• Fluency in English.

Preferred:

• Advanced degree in life sciences or related field.
• Experience in CRO environment.
• Ability to work with leadership, analytical skills, and business acumen.
• Strong presentation and interpersonal skills.
• High integrity and leadership qualities.
• Ability to inspire and lead teams, foster ownership, and drive productivity.
• Results-oriented, accountable, motivated, and flexible.
• Effective negotiation, conflict management, and decision-making skills.
• Excellent verbal and written communication skills.
• Occasional travel may be required.

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