Senior Clinical Manager

Work Schedule

Environmental Conditions

Job Description

Join Us as a Senior Manager in our Clinical Operations team Make an Impact at the Forefront of Innovation.

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs spanning 2700 clinical trials across 100 countries in the last 5 years.

As a Senior Manager Clinical Operations you will oversee train resource coach and performance manage a team of CRAs. 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 companys SOPs and WPDs. You will also work in collaboration with the leadership team for resourcing needs.

What Youll 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 at a country level.
• 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 departments 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).
• Minimum of 3 years of managing CRAs.

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 companys 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. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.

Apply today to help us deliver tomorrows breakthroughs.