Project Manager / Senior Project Manager - FSP Team

Submission for the position: Project Manager / Senior Project Manager - FSP Team - (Job Number: 182022)

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, youwill 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.

Responsibilities:

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 PMwill 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.

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, youwill 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.

Responsibilities:

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 PMwill 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. Qualifications: 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) Qualifications: 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) Submission for the position: Project Manager / Senior Project Manager - FSP Team - (Job Number: 182022)