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Associate Director CDM - Project/Vendor Management

Pharmaceutical Product Development (PPD)

NC-Wilmington-Wilmington NC HQ

Submission for the position: Associate Director CDM - Project/Vendor Management - (Job Number: 173241)Homebased U.S/CanadaFull-time Regular w/ Benefits

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

Are you a data and a people person? Here’s your team. We manage and clean the data collected in a clinical trial — from the design and build of the database and edit checks, through the entry and cleaning of data to the final delivery of clinical trial data. We work closely with the project teams and clients to identify best practices and processes, meet and exceed our clients’ needs, and do the right thing to earn their trust.

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:

Within Clinical Data Management(CDM), we work in a number of Clinical Data Management Systems (CDMSs). These systems are not owned or hosted by PPD. These systems are developed and maintained by an external vendor. We work closely with the vendor to deliver projects to our Clients. There are a number of roles and tasks necessary to successfully manage the vendors and PPD’s use of their CDMSs

Essential Functions:Primary vendor contact. Develops and manages CDM vendor relationship. Meets regularly with vendor contact to address current issues, challenges, items of interest. Meetings include weekly/monthly meetings with vendor primary contact and less frequent (typically quarterly) governance meetings.Understands the vendor offerings, roadmap and how PPD utilizes the vendor system/products.Facilitator of and active participant in the CDMS Solution Team. CDMS Solution Team responsibilities include:Works with vendor, project teams and PPD management on items specific to their expertiseProvides support to the functional groupsEscalation point for Vendor Application and Service items not addressed internallyProvide support to other teams on CDMS related items they have faced/addressedAssesses/validates upgradesDefines and documents training, processes, procedures and functionalityProvides awareness to functional groups of vendor offerings, system upgrades, training, processes, procedures and functionalityParticipates in and develops stakeholder communicationsEscalation point for CDMS items not addressed by vendorIdentifies trends in vendor issues, escalations, challenges and questions and develops and implements action plans to addressWorks with vendor and internal representatives to recommend/identify vendor related strategies and improvementsEngages in cross functional vendor management initiativesWorks with PPD QA Vendor Management to identify vendor specific issues for PPD QA audit of vendorMaintains CDMS business development libraryCoordinates vendor contract and finance managementMonitor service level metrics and key performance indicators and develops/proposes action plans to address missed performance expectationsContact for scheduling demos provided by vendorHomebased U.S/CanadaFull-time Regular w/ Benefits

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

Are you a data and a people person? Here’s your team. We manage and clean the data collected in a clinical trial — from the design and build of the database and edit checks, through the entry and cleaning of data to the final delivery of clinical trial data. We work closely with the project teams and clients to identify best practices and processes, meet and exceed our clients’ needs, and do the right thing to earn their trust.

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:

Within Clinical Data Management(CDM), we work in a number of Clinical Data Management Systems (CDMSs). These systems are not owned or hosted by PPD. These systems are developed and maintained by an external vendor. We work closely with the vendor to deliver projects to our Clients. There are a number of roles and tasks necessary to successfully manage the vendors and PPD’s use of their CDMSs

Essential Functions:Primary vendor contact. Develops and manages CDM vendor relationship. Meets regularly with vendor contact to address current issues, challenges, items of interest. Meetings include weekly/monthly meetings with vendor primary contact and less frequent (typically quarterly) governance meetings.Understands the vendor offerings, roadmap and how PPD utilizes the vendor system/products.Facilitator of and active participant in the CDMS Solution Team. CDMS Solution Team responsibilities include:Works with vendor, project teams and PPD management on items specific to their expertiseProvides support to the functional groupsEscalation point for Vendor Application and Service items not addressed internallyProvide support to other teams on CDMS related items they have faced/addressedAssesses/validates upgradesDefines and documents training, processes, procedures and functionalityProvides awareness to functional groups of vendor offerings, system upgrades, training, processes, procedures and functionalityParticipates in and develops stakeholder communicationsEscalation point for CDMS items not addressed by vendorIdentifies trends in vendor issues, escalations, challenges and questions and develops and implements action plans to addressWorks with vendor and internal representatives to recommend/identify vendor related strategies and improvementsEngages in cross functional vendor management initiativesWorks with PPD QA Vendor Management to identify vendor specific issues for PPD QA audit of vendorMaintains CDMS business development libraryCoordinates vendor contract and finance managementMonitor service level metrics and key performance indicators and develops/proposes action plans to address missed performance expectationsContact for scheduling demos provided by vendor

Education/Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10 years).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 & Abilities:

Proven ability to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global SOPs and client expectationsStrong attention to detail and skill with numbersAbility to work on extremely complex problems where analysis requires reevaluating various factorsExcellent ability to prioritize and handle multiple high profile prioritiesExcellent written/ verbal communication skills with a strong command of English language and grammar; expert organizational and analytical/problem solving skills; strong customer focus and excellent interpersonal skillsProven ability to identify project risks and to effectively evaluate and develop plans to mitigate those risksAbility to maintain a high degree of confidentiality with clinical data and client's proprietary dataProven ability to set and meet, for self and team(s), timelines or be able to recognizeand schedule changes in response to project demandsDemonstrated ability to forecast project resourcing, project timeline planning and adherence to timelinesManagement responsibilities:This role is intended to be a individual contributor role. Direct reports could be added in the future.

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:

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.Ability 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. 10-20% annual possible.

PPD Defining Principles:

- 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

Education/Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10 years).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 & Abilities:

Proven ability to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global SOPs and client expectationsStrong attention to detail and skill with numbersAbility to work on extremely complex problems where analysis requires reevaluating various factorsExcellent ability to prioritize and handle multiple high profile prioritiesExcellent written/ verbal communication skills with a strong command of English language and grammar; expert organizational and analytical/problem solving skills; strong customer focus and excellent interpersonal skillsProven ability to identify project risks and to effectively evaluate and develop plans to mitigate those risksAbility to maintain a high degree of confidentiality with clinical data and client's proprietary dataProven ability to set and meet, for self and team(s), timelines or be able to recognizeand schedule changes in response to project demandsDemonstrated ability to forecast project resourcing, project timeline planning and adherence to timelinesManagement responsibilities:This role is intended to be a individual contributor role. Direct reports could be added in the future.

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:

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.Ability 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. 10-20% annual possible.

PPD Defining Principles:

- 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

Submission for the position: Associate Director CDM - Project/Vendor Management - (Job Number: 173241)

Job posted: 2020-08-28

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