PPD’s mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you!  We know that meaningful results not only require the right approach, but also the right people.  We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams. 

Our global Clinical department consists of colleagues with institutional knowledge, in-depth therapeutic experience, and robust operational tools. Together, we help clients define and develop clinical programs, minimize delays and execute high-quality, cost-efficient clinical studies. 

As a manager at PPD, you will oversee daily line management responsibilities of an assigned team and serve as positive leadership and professional role model for respective staff. 

THE PPD FSP SOLUTION: 

PPD's Functional Service Partnership division partner with and serve as an extension of our PPD team, supporting our customers key functions.  We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality. We_ deploy the same top-tier talent in ALL engagement models_. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success.

Joining within our PPD FSP functional area, allows you to join the renowned PPD CRO and still gain invaluable client dedicated experience. _ _

OUR FSP CLIENT

This role will be embedded within a client dedicated team. You will work alongside the clients own experienced personnel, as well as PPD colleagues to deliver leading edge clinical support.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees. 

Summarized Purpose:   

Manages, selects, trains, resources, coaches and performance management of respective staff, which may be inclusive of Clinical Research Associates, Clinical Trial Coordinators, Remote Monitors and other clinical 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 PPD. 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:   

• 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. 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 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.

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

Working Environment: 

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.  Below is listed the working environment/requirements for this role: 

• Work is performed in an office environment with exposure to electrical office equipment.

• Frequently drives to site locations and frequently travels both domestic and international.

Physical Requirements:

• Frequently stationary for 6-8 hours per day.

• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

• Moderate mobility required.

• Occasional crouching, stooping, bending and twisting of upper body and neck.

• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

• Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.

• Frequently interacts with others, relates sensitive information to diverse groups both internally & externally.

• Ability to apply basic principles to solve conceptual issues.

• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.

• Regular and consistent attendance.

​​​​​​​AS A CONDITION OF EMPLOYMENT WITH PPD, PART OF THERMO FISHER SCIENTIFIC, IN THIS ROLE, YOU MUST HAVE RECEIVED YOUR COVID-19 VACCINE AND YOU MUST DISCLOSE PROOF OF YOUR VACCINATION STATUS UPON EMPLOYMENT.

As the world’s leader in serving science, Thermo Fisher Scientific's professionals develop critical solutions—and build rewarding careers. They help customers in finding cures for cancer, protecting the environment, making sure food is safe, and so much more. When you #StartYourStory with Thermo Fisher, you are guaranteed meaningful work - both personally and professionally.