Manager Office H/F

JR France; Saint-Herblain; Sur place; EUR 55 000 - 70 000; Plein temps

Résumé du poste

A leading company in the clinical research sector is seeking a Site Start-up Manager to oversee project delivery and personnel development. The role involves ensuring adherence to standards, training, and resource management. Candidates should have significant experience in clinical research and leadership skills to succeed in a dynamic environment.

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 is required.

Responsabilités

• Manage and oversee day-to-day SSU activities.
• Ensure compliance with regulatory requirements and SOPs.
• Develop and mentor SSU personnel for quality standards.

Connaissances

People management

Strong communication

Organizational skills

Analytical skills

Formation

Bachelor's degree in life sciences

Advanced degree in life sciences (preferred)

Outils

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. Emphasizes effective resourcing and personnel development. Provides oversight and leadership for site start-up project delivery; coordinates inter-departmental and client communication; helps resolve administrative, personnel, and project issues.

Essential functions include but are not limited to:

• Develop, mentor, manage, and coach SSU personnel to maintain Precision’s quality standards.
• Advocate for individual career development and responsibility.
• Maintain routine 1:1 meetings with SSU personnel for task management and career development.
• Serve as SME support for Site Start-up activities.
• Ensure SSU personnel adhere to quality standards and compliance with SOPs, guidelines, project plans, and regulatory requirements.
• Ensure proper resources, training, materials, and system access for SSU personnel.
• Contribute to training plan development and ensure training goals are met.
• Ensure administrative compliance (time entry, training, billing, expenses).
• Participate in interviewing new SSU personnel and support onboarding in collaboration with HR.
• Develop and maintain standards and processes for staff and ensure consistent quality execution.
• Manage resource allocation and FTE distribution per project in line with budgets.
• Provide ongoing feedback, coaching, and conduct performance reviews.
• Lead department meetings and internal initiatives.
• 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 with extensive Site Start-up experience.
• Leadership experience or demonstrated competencies.
• Knowledge of GCP/ICH guidelines and clinical development process.
• People management skills.
• Experience with resource management, teamwork, 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.
• Demonstrated analytical skills, business acumen, and leadership qualities.

Competencies:

• Ability to work with leadership to understand customer needs.
• Strong presentation and communication skills.
• High integrity, ethical standards, and leadership ability.
• Results-oriented, accountable, flexible.
• Effective influence, negotiation, and conflict management skills.
• Excellent time management, decision-making, and interpersonal skills.
• Willingness to travel occasionally.

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