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Manager Offre Microsoft F/H

JR France

Montauban

Sur place

EUR 50 000 - 80 000

Plein temps

Il y a 10 jours

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Résumé du poste

A leading company is seeking a Site Start-up Manager to oversee personnel and ensure compliance with standard operating procedures in clinical research. This role focuses on personnel development, project delivery, and coordination with cross-functional teams, requiring a strong background in life sciences and extensive site start-up experience.

Qualifications

  • Minimum 6 years in clinical research with Site Start-up experience.
  • Leadership experience or proven competencies required.
  • Fluency in English and knowledge of GCP/ICH guidelines.

Responsabilités

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

Connaissances

People management
Team collaboration
Communication
Organizational skills
Strategic planning
Risk management
Change management
Negotiation
Conflict management

Formation

Bachelor's 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. Emphasizes 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 for task management and career growth.
  • Serve as SME support for Site Start-up activities.
  • Ensure SSU personnel work to the highest quality standards and maintain compliance with SOPs, guidelines, project plans, and regulatory requirements.
  • Ensure proper resources, training, and access for SSU personnel to meet expectations.
  • Contribute to training plan development and accountability.
  • Ensure compliance with administrative tasks such as time entry, billing, and expense reporting.
  • 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 and ensure consistent quality execution.
  • Participate in resource planning and manage FTE allocation per project.
  • Provide ongoing feedback, development, and coaching; conduct performance reviews.
  • Lead department meetings and communicate high-level updates.
  • 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, team collaboration experience, proficiency in Microsoft Office and clinical software (CTMS, eTMF, EDC), strong communication and organizational skills, strategic planning, risk and change management, fluency in English.

Preferred: Advanced degree in life sciences, CRO experience, and demonstrated leadership competencies.

Competencies:
  • Ability to work with leadership and understand customer needs.
  • Strong analytical, presentation, and interpersonal skills.
  • High integrity, leadership, and motivational skills.
  • Results-oriented, accountable, and flexible.
  • Effective negotiation, conflict management, and time management skills.
  • Occasional travel may be required.

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