Manager Offre Microsoft F/H

JR France; Tours; Sur place; EUR 65 000 - 90 000; Plein temps

Résumé du poste

A leading company in the clinical research field is seeking a Site Start-up Manager to oversee and manage daily activities of start-up personnel. The ideal candidate will have significant experience in clinical research, particularly in site start-up, alongside strong leadership and management skills. This role focuses on ensuring compliance with quality standards, developing personnel, and coordinating resources for successful project execution. Candidates should hold a relevant degree and have proven expertise in managing teams effectively.

Qualifications

• At least 6 years in clinical research with extensive Site Start-up experience.
• Leadership experience and knowledge of GCP/ICH guidelines.
• People management skills and resource management experience.

Responsabilités

• Manage day-to-day activities of Site Start-up personnel.
• Provide oversight and leadership for project delivery.
• Ensure compliance with procedures and training goals.

Connaissances

Leadership

Communication

Organizational Skills

Analytical Skills

Negotiation

Formation

Bachelor's degree in life sciences or related field

Advanced degree (preferred)

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, 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 of the job include but are not limited to:

• Develop, mentor, manage, and coach SSU personnel to ensure quality standards are maintained. Advocate for individual career development and responsibility.
• Maintain routine 1:1 meetings with SSU personnel to manage tasks and career growth.
• Serve as SME support for Site Start-up activities.
• Ensure SSU personnel work according to quality standards and comply with SOPs, guidelines, project plans, and regulatory requirements.
• Ensure proper resources, training, and access for SSU personnel to meet their responsibilities.
• Contribute to training plan development and ensure training goals are met.
• Ensure administrative compliance (e.g., time entry, billing, expenses).
• Participate in the interview process for new SSU personnel.
• Support onboarding training in collaboration with HR and other departments.
• Develop and maintain standards and processes for staff, ensuring consistent quality.
• Participate in resource planning and manage FTE allocation per project.
• Provide ongoing feedback, coaching, and conduct performance reviews.
• Lead department meetings and communicate high-level updates to SSU personnel.
• Assist with 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 with extensive Site Start-up experience. Leadership experience and knowledge of GCP/ICH guidelines.

Other Required: People management skills, resource management experience, proficiency in Microsoft Office and clinical software (CTMS, eTMF, EDC), strong communication and organizational skills, strategic planning, risk and change management experience. Fluency in English.

Preferred: Advanced degree, CRO experience, and demonstrated leadership and strategic skills.

Competencies:

• Ability to work with leadership to understand customer needs.
• Strong analytical, presentation, negotiation, and interpersonal skills.
• High integrity, inspiring leadership, and team motivation.
• Results-oriented, accountable, flexible, and effective conflict management.
• Excellent time management and decision-making skills.
• Willingness to travel occasionally.

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