(Senior) Project Manager, FSP - Customer-dedicated

Job Description

Who is PPD Clinical Research Services? 

PPD is a leading global contract research organization.  Our purpose is to improve health. Our mission is to help customers deliver life-changing therapies. Our strategy is to bend the cost and time curve of drug development and optimize value for our customers.  PPD is now part of Thermo Fisher Scientific. As the world leader in serving science, our Mission is to enable our customers to make the world healthier, cleaner and safer. We are excited about the opportunities this combination brings to enhance our comprehensive end-to-end offering, enabling customers to move rapidly from scientific idea to approved medicine

The PPD FSP Solution

PPD's Functional Service Provider 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.  

PPD has an exciting opportunities for different level of Clinical Project Managers, to join us and be dedicated for one of our strategic global partners. You will be dedicated to the client projects, processes, working within their teams and systems on behalf of PPD.

The role is responsible for all clinical operational aspects for the assigned global clinical studies from preparation until closure.

Key responsibilities:

• Responsible for leading and guiding and overseeing the CROs and other (lab) vendors involved in the assigned clinical studies based upon metrics and plan
• Leading CRO contracts negotiations together with our vendor manager
• Providing input into and/or developing study related materials such as Clinical Protocol, Clinical Monitoring Plans, Data Management Plans, eCRF and completion guidelines, patient information and informed consent, site instructions for specimen collections, study drug order forms etc.
• Overseeing and tracking patient recruitment and pro-actively identifies ways to prevent recruitment delays
• Ensuring that study Trial Master File is maintained and up to date
• Ensuring clinical studies are conducted in compliance with ICH-GCP and other applicable legislations
• Reviewing monitoring reports, protocol deviations and data listings for studies to ensure reliable quality data are delivered and proactive identifies and solves issues/concerns
• Facilitating timely availability of investigational product supply on site and ensuring that clinical site accountability records on site are maintained
• Ensuring timely collection of documentation for adverse event safety monitoring and collaborating in submission of MedWatch reports to FDA, EMEA and other applicable regulatory authorities
• Ensuring timely SAE reporting to the responsible IRB and Competent Authority agencies according to the applicable (local) legislation
• Establishing and maintaining good relation with clinical site and study personnel - Co-monitoring CROs personnel upon predefined plan
• Pro-actively identifying and solving issues in the assigned clinical studies and timely escalating them to Project Manager or Senior Management, if needed
• Leading and guiding the internal clinical study team and chairing study team meetings
• Communicating in a transparent, clear way and motivating team members to work towards achieving clinical study goals
• Preparing of study timelines and budget and delivering studies within timelines, scope and budget, aligned with the clinical development plan
• Ensuring that the assigned studies are executed according to our quality standards
• Responsible for risk management of the assigned studies: performing (pre-)study risk assessment and ensuring that mitigation steps for potential risks are taken
• Responsible and contact person during inspections/audits for the assigned studies together with the Quality Assurance representative
• The Sr PM will also participate in activities other than study-related which include but are not limited to:
• - Providing input to the clinical development strategy/plan
• - Co-writing/maintaining SOPs within the Clinical Operations department

Education and Experience:

• Bachelor's degree or licensed certified health care training or equivalent combination of education and experience
• Previous biopharma/biotech experience preferred in a Study Management/PM role
• Experience with Oncology will be beneficial
• FSP experience would be ideal
• Has proven understanding and experience of working within clinical development (equivalent to 4-5 years)
• Can demonstrate evidence of a period of successfully managing and/or leading individuals/team
• Experience using project management software
• Solid understanding of how to craft and manage a project budget
• Must possess a valid passport, (travel approx 10%)

Knowledge, Skills and Abilities:

• Knowledge of the key principles of cross functional project management (Time, Quality, Cost) - Solid financial acumen
• Applies a range of negotiation techniques to achieve desired outcomes with evidence of commercial and organizational acumen
• Displays effective communication skills (listening, oral, written) and can communicate in English language (oral,written)
• Sound interpersonal skills, is flexible and adapts to changing situations
• Has the ability to persuade, convince, and influence or impress others
• Is organized, proficient at multi-tasking with good attention to detail
• Able to lead, motivate and coordinate teams. Coach/mentor team members as appropriate
• Able to delegate, effectively prioritizes own and workload of project team members
• Ability to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc
• Possesses cross cultural awareness and is able to adapt appropriately
• Has an understanding and appreciation of clinical research/development, including medical and therapeutic areas, phases and medical terminology
• Has experience with leading, liaising and coordinating cross-functional project teams
• Has knowledge/understanding of clinical development guidelines and Directives

If you are interested in learning more, please send upload your CV. Due to high level of applications, only short-listed candidates will be contacted.

Our 4i values: 

- Integrity - Innovation - Intensity - Involvement - 

If you resonate with our four principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.   Please note only short-listed candidates will be contacted.

Work Environment Requirements: 

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.    PPD® FSP: People Who Deliver | PPD Careers - Read about PPD employee experiences!  *LI-MP1