Manager Offre Microsoft F/H

JR France; Île-de-France; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

A leading company in the clinical research sector is seeking a Site Start-up Manager in Île-de-France. The role involves overseeing Site Start-up personnel, ensuring compliance with quality standards, and facilitating personnel development. The ideal candidate will have significant experience in clinical research and proven leadership abilities.

Qualifications

• At least 6 years in clinical research with extensive Site Start-up experience.
• Knowledge of GCP/ICH guidelines and clinical development process.
• Proficiency with clinical software and Microsoft Office.

Responsabilités

• Manage day-to-day activities of Site Start-up personnel to ensure quality standards.
• Coordinate project delivery and resolve administrative and personnel issues.
• Contribute to team development and conduct training.

Connaissances

Leadership

Communication

Organizational

Interpersonal

Strategic Planning

Risk Management

Change Management

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. 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:

• Develop, mentor, manage, and coach SSU personnel to maintain Precision’s quality standards. Promote individual career development and accountability.
• 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 comply with SOPs, guidelines, project plans, and regulations.
• Ensure proper resources, training, and access for SSU personnel to perform their roles.
• Contribute to training plan development and monitor training progress.
• Ensure compliance with administrative tasks such as time entry, billing, and expenses.
• Participate in the interview process for new SSU personnel.
• Support onboarding training for new personnel.
• Develop standards and processes for staff and ensure consistent execution.
• Manage FTE allocation per project to align with budgets and adjust as needed.
• Provide ongoing feedback, development, and coaching to team members.
• Participate in departmental planning and communication.
• 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 or proven competencies.
• Knowledge of GCP/ICH guidelines and clinical development process.

Other Required:

• People management skills.
• Experience working in team environments with resource management.
• Proficiency with Microsoft Office and clinical software (CTMS, eTMF, EDC, etc.).
• 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 and deliver presentations.
• High integrity, leadership, and motivational skills.
• Proven ability to influence, negotiate, and resolve conflicts.
• Excellent time management and decision-making skills.
• Willingness to travel occasionally.

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