Associate Manager/Manager, Clinical Operations

Associate Manager/Manager, Clinical Operations at Thermo Fisher Scientific (PPD)

PPD, part of Thermo Fisher Scientific, is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose to improve health!

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

The Role of Associate Manager/Manager, Clinical Operations

Our clinical department defines, develops and delivers clinical programmes. We ensure the highest-quality review of data and effective interaction with study sites, including on-site monitoring throughout a study, ensuring that patients receive needed care, as well as identifying and treating clinical trial participants.

The Associate Manager/Manager, Clinical Operations role involves managing, selecting, training, resourcing, coaching, and performance management of respective staff. This may include Clinical Administrative Staff (CAS), Clinical Scientists (CS), Clinical Research Associates (CRAs), Associate Clinical Research Associates (ACRAs), Clinical Trial Coordinators (CTC), and/or other clinical operations-focused personnel. This position emphasizes achieving results through metrics and key performance indicators to manage performance. You may also lead or contribute to initiatives aimed at enhancing departmental performance or improving company-wide processes. Collaboration with clinical operations senior management and executive staff on strategic planning and business development is required. The role acts as a point of escalation for performance concerns and training needs, ensuring adherence to the company's Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs). You will work in collaboration with the leadership team to address resourcing needs.

Key Responsibilities

• Performance management, providing coaching, mentorship, and work direction to staff.
• Support change management initiatives effectively.
• Conduct regular performance appraisals and career discussions with team members.
• Facilitate employee career development and growth.
• Interview, recruit, and select new staff members.
• Manage and conduct induction/orientation programs for all new employees, ensuring smooth assimilation.
• Ensure all staff CVs, training records, position profiles, and experience profiles are complete and up-to-date.
• Ensure timeliness and accuracy of timesheets and expense reports.
• Support allocation activities in line with the local resourcing process.
• Support activities of project leads/functional leads to optimize operational running of projects.
• Escalate any issues that may impact project deliverables appropriately.
• Deliver training on Working Practice Documents (WPDs), Standard Operating Procedures (SOPs), local requirements, and other subjects impacting clinical operations.
• Identify training gaps and ensure all training requirements are met.
• Contribute to the development of training programs where appropriate.
• Assure adherence to good ethical and regulatory standards.
• Alert management to quality issues, request QA audits as appropriate, and facilitate client and internal quality assurance audits as required.
• Manage and review systems (e.g., Activate, CTMS, Preclarus, Clarity) to evaluate employee and project metrics, KPIs, and general project status.
• Evaluate staff work, including conducting performance assessment visits (remote or on-site) to assess employee monitoring skills and project conduction when applicable.
• Participate in process improvement/development initiatives.
• Ensure understanding and facilitation of the risk-based monitoring approach.
• Provide input into bids and contribute to the procurement of new business where required.

Policy & Strategy

Interpret and administer policies, processes, and procedures that may affect sections and subordinate work units. This role requires full knowledge of your own area of functional responsibility.

Qualifications and Experience

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
• 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; both 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 team player with team building skills.
• Excellent interpersonal and conflict resolution skills.
• Advanced ability to utilize problem-solving techniques applicable to a constantly changing environment.
• Solid knowledge of medical/therapeutic areas and medical terminology.

What We Offer

At PPD clinical research services, we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore you will benefit from an award-winning learning and development program, ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.

Our Values

Our 4i Values: Integrity – Innovation – Intensity – Involvement.

If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!

Key skills/competency

• Clinical Operations Leadership
• Performance Management
• ICH/GCP Compliance
• Clinical Trial Monitoring
• Staff Development & Coaching
• SOPs & WPDs Implementation
• Project Metrics & KPIs
• Quality Assurance Audits
• Risk-Based Monitoring
• Strategic Planning Support