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Project Manager / Senior Project Manager - FSP Team

PPD is a leading global contract research organization.  At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

We partner directly with our clients to deliver projects from study start-up through close-out activities. In Project Management, you will oversee the delivery of PPD groups collaborating to support our clients.  In short, you are a crucial piece in earning the trust of our clients.


This exciting opportunity is to support our client located in Boston, MA.  Ideally this candidate will have clinical study operational experience in phases I, II and III of drug development and is an operational expert in the clinical study activites from start-up, execution, to closure.  As a client-dedicated Project Manager, you will be the "operational clinical study voice" for the assigned studies, both internally and externally.  Own the timelines of a clinical study project and is accountable for keeping the study on track.  Excel in establishing good and effective internal and external working relationships.




Responsible for all clinical operations aspects for the assigned global clinical studies from preparation to closure.


Responsible for leading, guiding and overseeing the CROs and responsible for overseeing vendors involved in the assigned clinical studies based upon metrics and plans.


Leading CRO contracts negotiations together with the argenx Director Vendor Management


Providing input into and/or developing study related materials such as Clinical Study Protocol, Clinical Monitoring Plans, Data Management Plans, eCRF and completion guidelines, Patient Information and Informed Consent, site instructions for specimen collections, and study drug order forms etc.


Overseeing and tracking patient recruitment and pro-actively identifying 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 collaborates 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 Lead Project Manager, Head of Clinical Operations 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 the argenx 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 Client-Dedicated 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



Grow within Project Management with opportunities to advance to Associate Director and Director within Project Management.  Or grow your career in other departments across PPD.


At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk - our award winning training programs speak for themselves.

To learn how PPD can advance your career, apply now!
What To Expect Next
We look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview.
Education and Experience:
Bachelor’s degree or University degree – medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience
Minimum of 5 years of experience in Clinical Operations and managing CROs and vendors
Biotech experience is a plus
Auto-immune and/or oncology clinical study background is a plus


Knowledge, Skills and Abilities:
 Knowledge of ICH-GCP and other applicable legislation to successfully execute the clinical study
Experience with tools and systems for managing clinical studies (MS project, study progress and metric systems, eCRF databases) 


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:

  • Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner
  • Able to work upright and stationary for typical working hours
  • Able to use and learn standard office equipment and technology with proficiency
  • Able to perform successfully under pressure while prioritizing and handling multiple projects or activities
  • May require travel (Recruiter will provide more details) 

Apply Now

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