Manager Offre Microsoft F/H

JR France; Le Plessis-Robinson; Sur place; EUR 50 000 - 70 000; Plein temps

Résumé du poste

A leading company in the clinical research industry seeks a Site Start-up Manager to lead day-to-day activities and personnel development. The successful candidate will ensure compliance with regulatory standards and manage resources effectively while promoting career growth within a dynamic team. This role requires strong leadership skills and extensive experience in clinical trials.

Qualifications

• Minimum 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 and mentor Site Start-up personnel to ensure quality standards.
• Oversee project delivery and resolve operational issues.
• Participate in departmental meetings and contribute to internal initiatives.

Connaissances

Leadership

Communication

Organizational skills

Interpersonal skills

Analytical skills

Formation

Bachelor's degree in life sciences or related field

Outils

Clinical Trial Management Systems (CTMS)

Electronic Trial Master File (eTMF)

Electronic Data Capture (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 of the job include but are not limited to:

1. Develop, mentor, manage, and coach SSU personnel to ensure quality standards are maintained. Promote career development and accountability.
2. Maintain routine 1:1 meetings with SSU personnel to manage tasks and career growth.
3. Serve as SME support for Site Start-up activities.
4. Ensure SSU personnel work to the highest quality standards and comply with SOPs, guidelines, project plans, and regulatory requirements.
5. Ensure proper resources, training, and access for SSU personnel to perform their duties.
6. Contribute to training plan development and monitor training goals.
7. Ensure administrative tasks (time entry, training, billing, expenses) are completed accurately.
8. Participate in the interview process for new SSU personnel.
9. Support onboarding and training of new staff.
10. Develop standards and processes for staff and ensure consistent quality execution.
11. Manage FTE allocation to align with project budgets and assess as needed.
12. Provide ongoing feedback, coaching, and conduct performance reviews.
13. Participate in departmental meetings and internal initiatives.
14. Perform other duties as assigned.

Qualifications:

• Bachelor's degree in life sciences or related field, or equivalent experience.
• Minimum 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 team experience.
• Experience with resource management 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.
• Ability to lead, inspire, and create ownership among team members.
• Results-oriented with high integrity.
• Travel may be required.

Any data provided will be stored according to our Privacy Policy. For CA applicants, see our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. For accommodations, contact [emailprotected].

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