FSP CRA People Manager

ThermoFisher Scientific; México; À distance; MXN 600 000 - 1 000 000; Plein temps

Résumé du poste

Thermo Fisher Scientific is seeking an Associate Manager Clinical Operations in Mexico to lead a dedicated clinical operations team. You will coach staff, conduct performance reviews, and drive adherence to SOPs and regulatory standards while collaborating with leadership on resourcing and project execution.

You will oversee training delivery, ensure up-to-date documentation, and manage daily operations including timesheets, budgets, and quality assurance activities.

Qualifications

• 5+ years clinical operations experience; depth in monitoring and oversight.
• 1+ year of leadership responsibility and people management.
• Familiarity with ICH/GCP, FDA guidelines and SOP adherence.

Responsabilités

• Oversee and coach a team of clinical operations staff.
• Conduct regular performance appraisals and career discussions.
• Lead induction/orientation programs for new staff and ensure training records are current.
• Ensure timesheets and expense reports are accurate and timely.
• Support resource allocation and project leadership to optimize operations.
• Deliver training on WPDs and SOPs and identify training gaps.
• Monitor and ensure compliance with regulatory and ethical standards.
• Facilitate QA audits and coordinate internal/external quality assurance activities.
• Analyze staff and project metrics using CTMS and related tools.
• Participate in process improvements and risk-based monitoring initiatives.

Connaissances

Leadership

Mentoring

Clinical monitoring

SOP knowledge

Regulatory understanding

Formation

5+ years in clinical operations

Outils

CTMS

Clarity

Preclarus

Activate

Description du poste

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as an Associate Manager Clinical Operations – Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As an Associate Manager Clinical Operations, you will oversee, train, resource, coach and performance manage a team, which may be inclusive of various clinical operations focused staff. You will focus on end results using metrics and key performance indicators to lead performance. You will act as point-of-escalation regarding performance concerns and training needs to ensure adherence to the company's SOPs and WPDs. You will also work in collaboration with the leadership team for resourcing needs.

What You’ll Do:

• Manages staff, providing coaching, mentorship and work direction.
• Conducts regular performance appraisals and career discussions with staff. Facilitates employee career development. Interviews, recruits and selects staff.
• Manages and conducts induction/orientation programs for all new employees, ensuring their smooth assimilation into the company.
• Ensures all staff CVs, training records, position profiles and experience profiles are complete and up-to-date. Ensures timeliness and accuracy of timesheets and expense reports.
• Supports allocation activities per the local resourcing process. Supports activities of project leads/functional leads to optimize the operational running of projects. Raises appropriately any issues which may impact project deliverables.
• Delivers training on Working Practice Documents (WPDs) and Standard Operating Procedures (SOPs), local requirements and any other subjects that impact on clinical operations. Identifies training gaps and ensures that training requirements are met. May contribute to development of training programs, where appropriate.
• Assures adherence to good ethical and regulatory standards.
• Alerts management to quality issues, request QA audits as appropriate, and facilitate client and internal quality assurance audits as required.
• Handles and reviews systems (e.g. Activate, CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs and general project status.
• Evaluates work of staff, including conducting PAVs (either remote or on-site) to thoroughly evaluate the employee monitoring skills and project conduction when applicable.
• Participates in process improvement/development initiatives.
• Ensures understanding and facilitation of the risk-based monitoring approach.
• May provide input into bids and contribute to the procurement of new business where required.
• Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required.
• May lead or contribute to initiatives that enhance the department's performance or lead to process improvement across the company.

Education and Experience Requirements:

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
• 1+ year of leadership responsibility

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Advanced mentoring/leadership/supervisory skills
• Excellent clinical trials monitoring skills; Remote and on-site
• Demonstrated understanding of or ability to learn the company’s SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, FDA guidelines)
• Demonstrated ability to evaluate medical research data
• Strong organizational and negotiation skills
• Strong attention to detail
• Advanced written and oral communication skills
• Good knowledge of English language and grammar
• Demonstrated use of computer to include data entry, archival and retrieval
• Ability to travel as needed
• Excellent teammate with team building skills
• Excellent interpersonal and conflict resolution skills
• Advanced ability to utilize problem-solving techniques applicable to constantly changing environment
• Solid knowledge of medical/therapeutic areas and medical terminology

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.