Manager, Clinical Operations, FSP

Work Schedule

Environmental Conditions

Job Description

PD, 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.   

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. 

Summarized Purpose:

Manages, selects, trains, resources, coaches and performance management of respective staff, which may be inclusive of CAS, CS, CRAs, ACRAs, CTC, and/or other clinical operations focused staff. Focuses on end results using metrics and key performance indicators to manage performance. May lead or contribute to initiatives that enhance the department's performance or lead to process improvement across the company. Collaborates with clinical operations senior management and executive staff on strategic planning and business development as required. Acts as point-of-escalation regarding performance concerns and training needs to ensure adherence to the company's SOPs and WPDs. Works in collaboration with the leadership team for resourcing needs.

Essential Functions:

• Performance management, providing coaching, mentorship and work direction.

• Support change management,

• 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.

• Escalates 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.

• Manages 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 performance assessment visits (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.

Policy & Strategy

Interprets and administers policies, processes, and procedures that may affect sections and subordinate work units. Requires full knowledge of own area of functional responsibility.

Qualifications:

Education 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; 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 constantly changing environment

• Solid knowledge of medical/therapeutic areas and medical terminology

Management Role:

Manages experienced professionals and / or subordinate management who exercise latitude and independence in their assignments. Often heads one or more sections or a small department.

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 at PPD clinical research services you will benefit from an award-winning learning and development programme, 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 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!