Senior/Study Manager (Sr/CTM, Sr/PM) - Top Tier Biopharmaceutical - FSP, Customer-Dedicated

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Job description

* Who is PPD? *

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.

* The PPD FSP Solution: *

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

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.

* 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.

* Position Purpose: *

* The Study Manager has global responsibility for one or more studies of moderate complexity generally with responsibility for all study management aspects of assigned studies
* Leads and manages the tactical execution of one or more clinical studies from study startup through database close.
* Provides quality oversight to the Contract Research Organization (CRO) and of the CRO deliverables related to study execution.
* Leads and coordinates the execution of a clinical trial from Study start-up through Database close and inspection readiness to ensure timely delivery of quality study data. Study Managers may also input to and support compilation of sections to Clinical Study Reports.
* Will provide leadership to the teams in the setting of realistic recruitment targets and delivery milestones as the single point of accountability for detailed study start-up and monitoring plans and for delivery to the agreed plans.
* Works with functional lines and directly with CRO line functions to resolve or triage site level issues.
* Will drive decision making and work closely with the Clinical Project Manager to provide input to operational strategy.
* For studies where more than one Study Manager is assigned, may be required to act as 'lead' study manager, and will coordinate activities of the other Study Managers assigned.

*Primary Duties:*

* Accountable for the development of realistic detailed study startup and monitoring plans
* Accountable for conducting country level feasibility in collaboration with Global Clinical Trial Execution and CROs, reviewing Pre-trial Assessment outputs, approving sites, and assessing site activation plans
* Leads study risk planning process in context of site and subject
* Coordinate study/protocol training & investigator meetings
* Develops and provides key inputs to Clinical Trial Budget (e.g., Per Subject Costs)
* Accountable for the delivery of the study against approved plans
* Leads inspection readiness activities related to study management and site readiness
* May produce or review model Informed Consent Document (ICD) and study/country/site level ICD, as appropriate
* May expand study design document into approved protocol template while incorporating input from other team members (e.g., Clinician, Clinical Pharmacology Lead, Supply Chain Lead, Statistician, Outcomes Research Representative, Clinical Assay Group, etc.)

*Qualifications:*

* Education and Experience *:

Training and Education Preferred:

* Extensive global clinical trial/study management experience
* Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
* BS/Nurse - minimum of 5 years relevant experience
* MS/PhD - minimum of 3 years relevant experience

Prior Experience Preferred:

* Demonstrated study management / leadership experience
* Demonstrated oversight of CROs
* Demonstrated experience in managing Per Subject Costs, vendor & ancillary, and monitoring costs projections & spend

Skills:

* Understands how to work with vendors to accomplish tasks
* Ability to interpret study level data & translate and identify risks
* Ability to proactively identify & mitigate risks around site level in study execution
* Understands feasibility of protocol implementation
* Country level cultural awareness and strong interpersonal skills
* Keen problem-solving skills
* Excellent communication skills, both written and verbal. Must be fluent in English.
* Detail oriented & possesses technical expertise (e.g., spreadsheets, metrics & data flow management)

What we offer:

At PPD we hire the best, develop ourselves and each other, and recognise 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 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 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 organisation but with a local feel.

- We have a strong will to win - We earn our customer's trust - We are gamechangers - We do the right thing -We are one PPD -

If you resonate with our five 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 that due to the high volume of applications, only short-listed candidates will be contacted.

PPD is an equal employer.

*LI-MP1