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Digital eCOA Project Specialist (remote)

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.

We offer flexible trial solutions across the decentralized (DCT) spectrum to increase patient access and improve the patient experience, resulting in time efficiencies and data quality enhancements.

PPD Digital applies solutions drawing upon our operational, patient centered research and regulatory expertise. We design the optimal flexible strategy to extend patient reach and enhance data collection utilizing PPD assets and industry-leading technology and healthcare organizations.

Our solutions fit the trial to the patient, rather than the patient to the trial. We overcome the geographic barriers associated with the traditional brick-and-mortar site visit and reduce the patient burden through a compelling patient-centered experience integrated seamlessly into everyday life.

About the Position:

We have an exciting position open for a Digital Project Specialist. This role functions as a junior Project Manager in support of digital projects, virtual trials and their operational needs.

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: Supports digital enablement (wearables, eCOA, etc.) implementation projects in a project management capacity Manages internal resources, eClinical technology partners, translation vendors, and instrument copyright holders. May own one or more of these relationships at the department level. Develops UAT scripts for eCOA implementation Supports project scoping activities Initiates and prepares, reviews and finalizes all project/program plans required by government/client contracts by reviewing contract and communicating with functional area leads. Coordinates project/program/protocol specific and therapeutic area training needs. Tracks and follows up on all training, non-disclosure agreements, and security clearance requests as required. Schedules, leads and follows up on pre-identified meetings. May be internal and/or external. Ensures compliance to established project-specific parameters, authority approval, and client expectations. Identifies and assesses legal, financial and operational risks in accordance with company and client considerations, and escalates to appropriate level of the organization per established processes. Performs intermediate project financial management tasks as assigned. Acts as task order/work assignment lead on small scopes of work for contracts/projects of low-moderate complexity. Ensures guidelines and processes are followed for efficient escalation of out of parameter issues as appropriate. Provides training and guidance to junior team members. Executes periodic quality reviews and peer feedback and completes required reports.

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.

We offer flexible trial solutions across the decentralized (DCT) spectrum to increase patient access and improve the patient experience, resulting in time efficiencies and data quality enhancements.

PPD Digital applies solutions drawing upon our operational, patient centered research and regulatory expertise. We design the optimal flexible strategy to extend patient reach and enhance data collection utilizing PPD assets and industry-leading technology and healthcare organizations.

Our solutions fit the trial to the patient, rather than the patient to the trial. We overcome the geographic barriers associated with the traditional brick-and-mortar site visit and reduce the patient burden through a compelling patient-centered experience integrated seamlessly into everyday life.

About the Position:

We have an exciting position open for a Digital Project Specialist. This role functions as a junior Project Manager in support of digital projects, virtual trials and their operational needs.

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: Supports digital enablement (wearables, eCOA, etc.) implementation projects in a project management capacity Manages internal resources, eClinical technology partners, translation vendors, and instrument copyright holders. May own one or more of these relationships at the department level. Develops UAT scripts for eCOA implementation Supports project scoping activities Initiates and prepares, reviews and finalizes all project/program plans required by government/client contracts by reviewing contract and communicating with functional area leads. Coordinates project/program/protocol specific and therapeutic area training needs. Tracks and follows up on all training, non-disclosure agreements, and security clearance requests as required. Schedules, leads and follows up on pre-identified meetings. May be internal and/or external. Ensures compliance to established project-specific parameters, authority approval, and client expectations. Identifies and assesses legal, financial and operational risks in accordance with company and client considerations, and escalates to appropriate level of the organization per established processes. Performs intermediate project financial management tasks as assigned. Acts as task order/work assignment lead on small scopes of work for contracts/projects of low-moderate complexity. Ensures guidelines and processes are followed for efficient escalation of out of parameter issues as appropriate. Provides training and guidance to junior team members. Executes periodic quality reviews and peer feedback and completes required reports.

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 2 years’ experience for level I role, 5 years’ experience for level II).

Knowledge, Skills and Abilities: Working knowledge of eCOA and/or clinical outcomes assessments (ClinROs and PROs) and their relevance in clinical research Has an understanding of the translation and linguistic validation process Able to manage external vendors according to project scope, budget, timelines and quality standards. Displays effective communication skills (listening, oral, written) and can communicate in English language (oral, written). Sound interpersonal skills, is flexible and adapts to changing situations. Has the ability to persuade, convince, and influence or impress others. Is organized, proficient at multi-tasking with good attention to detail. Able to coordinate tasks and teams. Ability to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc. Possesses cross cultural awareness and is able to adapt appropriately. Has an understanding and appreciation of clinical research/development, including medical and therapeutic areas, phases and medical terminology.

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 2 years’ experience for level I role, 5 years’ experience for level II).

Knowledge, Skills and Abilities: Working knowledge of eCOA and/or clinical outcomes assessments (ClinROs and PROs) and their relevance in clinical research Has an understanding of the translation and linguistic validation process Able to manage external vendors according to project scope, budget, timelines and quality standards. Displays effective communication skills (listening, oral, written) and can communicate in English language (oral, written). Sound interpersonal skills, is flexible and adapts to changing situations. Has the ability to persuade, convince, and influence or impress others. Is organized, proficient at multi-tasking with good attention to detail. Able to coordinate tasks and teams. Ability to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc. Possesses cross cultural awareness and is able to adapt appropriately. Has an understanding and appreciation of clinical research/development, including medical and therapeutic areas, phases and medical terminology.

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: 2021-04-05

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