Travel & expense managers

JR France; Arrondissement d'Évry; Sur place; EUR 55 000 - 75 000; Plein temps

Résumé du poste

A leading company in clinical research seeks a Site Start-up Manager to oversee and enhance the performance of their Site Start-up team. This role involves leading project delivery, ensuring compliance with regulations, and mentoring personnel. Candidates should possess extensive knowledge in clinical research, with a bachelor's degree in life sciences being essential. A competitive salary package is offered, along with opportunities for professional growth.

Qualifications

• At least 6 years in clinical research with extensive Site Start-up experience.
• Knowledge of GCP/ICH guidelines and clinical development process.
• Fluency in English required.

Responsabilités

• Manage day-to-day activities of Site Start-up personnel.
• Ensure quality standards and compliance with SOPs.
• Participate in the interview process for new SSU personnel.

Connaissances

Leadership

Communication

Organizational skills

Interpersonal skills

Analytical skills

Formation

Bachelor’s degree in life sciences

Advanced degree in life sciences

Outils

Microsoft Office

CTMS

eTMF

EDC

Description du poste

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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 include but are not limited to:

1. Develop, mentor, manage, and coach SSU personnel to ensure quality standards are maintained. Promote 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 adhere to quality standards and compliance with SOPs, guidelines, project plans, and regulatory requirements.
5. Ensure proper resources, training, and access for SSU personnel to meet their responsibilities.
6. Contribute to training plan development and ensure training goals are met.
7. Ensure administrative tasks (e.g., time entry, billing, expenses) are compliant.
8. Participate in the interview process for new SSU personnel and support onboarding.
9. Develop standards and processes for staff and ensure consistent quality execution.
10. Manage FTE allocation per project to align with budgets, with ongoing assessment and adjustment.
11. Provide ongoing feedback, development, and coaching, including performance reviews.
12. Lead department meetings for high-level communication.
13. Support internal initiatives and perform other duties as assigned.

Qualifications

Minimum Required:

• Bachelor’s degree in life sciences or related field, or equivalent experience.
• At least 6 years in clinical research, including extensive Site Start-up experience.
• Leadership experience or proven competencies.
• Knowledge of GCP/ICH guidelines and clinical development process.
• People management skills and resource management experience.
• Proficiency in 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 to understand needs.
• Strong analytical, presentation, and negotiation skills.
• High integrity and leadership qualities.
• Ability to inspire team excellence and ownership.
• Results-driven, accountable, and flexible.
• Effective influence and conflict management skills.
• Excellent communication skills.
• Willingness to travel occasionally.

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