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DCT Solutions Manager II/III

Pharmaceutical Product Development (PPD)

Multiple Locations

About PPD:

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!

About the Department:

PPD Digital is PPD’s dedicated business unit responsible to accelerate decentralized trials via strategic consultancy and excellence in execution.

Now, more than ever, it’s critical to have a strategy to implement decentralized trials in order to continue to advance and protect life-saving clinical research. PPD is pioneering digital capabilities and deploying solutions to streamline protocols, putting patient experience at the center of every design.

PPD’s extensive portfolio of digital trial solutions – from electronic patient consent to telehealth to hybrid and fully decentralized/virtual trials – enables biopharmaceutical customers to advance their current and planned clinical research programs.

About the Position:

The DCT Solutions Manager II / III supportsthe generation and execution of site and patient operational strategieson decentralized and/or digitally enabled trials, by collaborating with peers, vendors,and other involved PPD groups.

About our Culture, Career Advancement and Benefits:

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 well-being of our employees.

Job Description: Support the study lead on the development of the study management plan, together with team assignments and accountabilities and oversight of the virtual sites and related DCT vendors, i.e. home health nurse agencies. Manage the efforts of cross-functional project teams and vendors to support milestone achievements on decentralized and digitally enabled trials while managing study issues and obstacles. Serve as primary project contact with virtual sites and ensure communication is maintained and continuously improved and reporting schedules are adhered to. Oversee contracting and budget management with these vendors. Support UAT on any DCT platform. Report on project performance against contract, customer expectations and project baselines to management. Oversee all virtual site and digital patient documentation. Support helpdesk setup and device management. Lead problem solving and resolution efforts to include management of risk, contingencies and issues. Identify quality issues within the study through regular review of site communications, monitoring visit reports, data flow information and quality assurance audit findings to implement appropriate corrective action plans. Escalate findings and manage study issues and obstacles. Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles. Provide input for the development of proposals for new work and project budgets Provide input to line managers of their project team members performance relative to project tasks. Prepare and present project information at internal and external meetings Participate in proposal development.

*LI-NA1

*LI-Remote

About PPD:

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!

About the Department:

PPD Digital is PPD’s dedicated business unit responsible to accelerate decentralized trials via strategic consultancy and excellence in execution.

Now, more than ever, it’s critical to have a strategy to implement decentralized trials in order to continue to advance and protect life-saving clinical research. PPD is pioneering digital capabilities and deploying solutions to streamline protocols, putting patient experience at the center of every design.

PPD’s extensive portfolio of digital trial solutions – from electronic patient consent to telehealth to hybrid and fully decentralized/virtual trials – enables biopharmaceutical customers to advance their current and planned clinical research programs.

About the Position:

The DCT Solutions Manager II / III supportsthe generation and execution of site and patient operational strategieson decentralized and/or digitally enabled trials, by collaborating with peers, vendors,and other involved PPD groups.

About our Culture, Career Advancement and Benefits:

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 well-being of our employees.

Job Description: Support the study lead on the development of the study management plan, together with team assignments and accountabilities and oversight of the virtual sites and related DCT vendors, i.e. home health nurse agencies. Manage the efforts of cross-functional project teams and vendors to support milestone achievements on decentralized and digitally enabled trials while managing study issues and obstacles. Serve as primary project contact with virtual sites and ensure communication is maintained and continuously improved and reporting schedules are adhered to. Oversee contracting and budget management with these vendors. Support UAT on any DCT platform. Report on project performance against contract, customer expectations and project baselines to management. Oversee all virtual site and digital patient documentation. Support helpdesk setup and device management. Lead problem solving and resolution efforts to include management of risk, contingencies and issues. Identify quality issues within the study through regular review of site communications, monitoring visit reports, data flow information and quality assurance audit findings to implement appropriate corrective action plans. Escalate findings and manage study issues and obstacles. Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles. Provide input for the development of proposals for new work and project budgets Provide input to line managers of their project team members performance relative to project tasks. Prepare and present project information at internal and external meetings Participate in proposal development.

*LI-NA1

*LI-Remote

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 (level II) to 8 (level III) years).

Knowledge, Skills and Abilities: Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams Good planning and organizational skills to enable effective prioritization of workload Solid interpersonal and problem solving skills to enable working in a multicultural matrix organization Capable of working effectively in a changing environment with complex/ambiguous situations Familiarity with the practices, processes, and requirements of clinical monitoring Good judgment and decision making skills Effective oral and written communication skills, including English language proficiency Capable of evaluating workload against project budget and adjusting resources accordingly Sound financial acument and knowledge of budgeting, forecasting and fiscal management Strong attention to detail Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc. Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.

PPD values the health and well-being 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 minimal as-needed travel (0-10%)

PPD Defining Principles:

- We have a strong will to win - We earn our customer’s trust - We are game changers - 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 would love to hear from you.

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 (level II) to 8 (level III) years).

Knowledge, Skills and Abilities: Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams Good planning and organizational skills to enable effective prioritization of workload Solid interpersonal and problem solving skills to enable working in a multicultural matrix organization Capable of working effectively in a changing environment with complex/ambiguous situations Familiarity with the practices, processes, and requirements of clinical monitoring Good judgment and decision making skills Effective oral and written communication skills, including English language proficiency Capable of evaluating workload against project budget and adjusting resources accordingly Sound financial acument and knowledge of budgeting, forecasting and fiscal management Strong attention to detail Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc. Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.

PPD values the health and well-being 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 minimal as-needed travel (0-10%)

PPD Defining Principles:

- We have a strong will to win - We earn our customer’s trust - We are game changers - 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 would love to hear from you.

Job posted: 2021-03-26

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