Manager Offre Microsoft F/H

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

Résumé du poste

A leading company in clinical research is seeking a Site Start-up Manager to oversee daily operations and manage a team to ensure the successful delivery of site start-up projects. This role emphasizes leadership, personnel development, and compliance with regulatory standards, making it essential for someone with extensive experience in clinical research. The candidate will contribute to training and compliance, support hiring processes, and ensure consistent quality execution throughout the department.

Qualifications

• At least 6 years in clinical research with extensive Site Start-up experience.
• Proficiency with clinical software and strong communication skills.
• Leadership experience or proven competencies required.

Responsabilités

• Manage day-to-day activities of Site Start-up personnel.
• Ensure SSU personnel maintain quality standards and comply with guidelines.
• Participate in hiring processes, including CV review and interviews.

Connaissances

Leadership

Communication

Organizational skills

Interpersonal skills

People management

Strategic planning

Negotiation

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. Emphasizes 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. Promote individual career development and accountability.
2. Maintain routine 1:1 meetings with SSU personnel for task management and career growth.
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 regulations.
5. Provide resources, training, and access to systems for personnel.
6. Contribute to training plan development and ensure training goals are met.
7. Ensure administrative tasks compliance (time entry, training, billing, expenses).
8. Participate in hiring processes, including CV review and interviews.
9. Support onboarding training for new personnel.
10. Develop standards and processes, ensuring consistent quality execution.
11. Manage FTE allocation per project, aligning with budgets and adjusting as needed.
12. Provide ongoing feedback, development, and coaching; conduct performance reviews.
13. Lead department meetings and communicate high-level updates.
14. Support internal initiatives and perform other duties as assigned.

Qualifications:

• Bachelor's degree in life sciences or related field, or equivalent experience.
• At least 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.
• People management skills and team experience.
• Proficiency with Microsoft Office and clinical software (CTMS, eTMF, EDC).
• 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.
• Ability to work with leadership, analytical skills, and business acumen.
• Strong presentation and negotiation skills.
• High integrity and ethical standards.
• Leadership ability and environment creation for ownership and productivity.
• Results-oriented, accountable, motivated, and flexible.
• Effective influence, negotiation, and conflict management skills.
• Excellent communication skills.
• Occasional travel may be required.

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