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Associate Clinical Data Team Lead - Remote in U.S

Pharmaceutical Product Development (PPD)

NC-Wilmingto

Submission for the position: Associate Clinical Data Team Lead - Remote in U.S - (Job Number: 176284)Home based in the U.S

Full-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.

As an Associate Clinical Data Team Lead, you will help ensure the highest quality and effectiveness of clinical trial data. You will work directly with Senior Clinical Data Team Leads to create, monitor and close studies in a timely manner. This position also works with sites, customers, and other team members across PPD.

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:

Acts as the assistant lead data manager for one or more projects supporting the lead data manager by performing assigned tasks in study set up, data cleaning, database close-out and other associated tasks.

Essential Functions:

Applies relevant components of the project protocol to daily tasks with guidance.

Delivers study specific training to junior associates for assigned projects.

Coordinates data cleaning tasks and delegates to appropriate data management staff to ensure quality standards are maintained and project deliverable timelines are met.

Performs specified activities that contribute to the creation of database specifications, database build and user acceptance testing during database and edit check development.

Monitors for risks to deadlines and escalates appropriately.

Creates and maintains data management project documentation.

Participates in team and client meetings and supports the lead data manager with risk management on allocated projects.

Provides input into project forecasting of hours and identification of resource requirements.

Monitors study metrics and runs project-specific status reports for management.

Reviews data management deliverables for allocated projects following documented guidelines.

Produces project-specific status reports for management, PM and/or clients on a regular basis.

Home based in the U.S

Full-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.

As an Associate Clinical Data Team Lead, you will help ensure the highest quality and effectiveness of clinical trial data. You will work directly with Senior Clinical Data Team Leads to create, monitor and close studies in a timely manner. This position also works with sites, customers, and other team members across PPD.

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:

Acts as the assistant lead data manager for one or more projects supporting the lead data manager by performing assigned tasks in study set up, data cleaning, database close-out and other associated tasks.

Essential Functions:

Applies relevant components of the project protocol to daily tasks with guidance.

Delivers study specific training to junior associates for assigned projects.

Coordinates data cleaning tasks and delegates to appropriate data management staff to ensure quality standards are maintained and project deliverable timelines are met.

Performs specified activities that contribute to the creation of database specifications, database build and user acceptance testing during database and edit check development.

Monitors for risks to deadlines and escalates appropriately.

Creates and maintains data management project documentation.

Participates in team and client meetings and supports the lead data manager with risk management on allocated projects.

Provides input into project forecasting of hours and identification of resource requirements.

Monitors study metrics and runs project-specific status reports for management.

Reviews data management deliverables for allocated projects following documented guidelines.

Produces project-specific status reports for management, PM and/or clients on a regular basis.

Education/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 0 to 2 years).

Preferred experience would include but not limited to: understanding EDC(Electronic Data Capture) systems or clinical trail operations including sites, patient data and/or general clinical research operations.

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:

Good written/ verbal communication skills with a strong command of English language and grammar; good organizational, analytical/problem solving skills and attention to detail

Ability to apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, SOPs and client expectations

Ability to work productively with support and minimal supervision

Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data

Strong customer focus and excellent interpersonal skills

Proven flexibility and adaptability

Ability to work in a team environment and independently as needed

Ability to train and direct junior team members

Ability to set and meet timelines or be able to recognize and schedule changes in response to project demands

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 youEducation/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 0 to 2 years).

Preferred experience would include but not limited to: understanding EDC(Electronic Data Capture) systems or clinical trail operations including sites, patient data and/or general clinical research operations.

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:

Good written/ verbal communication skills with a strong command of English language and grammar; good organizational, analytical/problem solving skills and attention to detail

Ability to apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, SOPs and client expectations

Ability to work productively with support and minimal supervision

Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data

Strong customer focus and excellent interpersonal skills

Proven flexibility and adaptability

Ability to work in a team environment and independently as needed

Ability to train and direct junior team members

Ability to set and meet timelines or be able to recognize and schedule changes in response to project demands

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 youSubmission for the position: Associate Clinical Data Team Lead - Remote in U.S - (Job Number: 176284)

Job posted: 2020-10-13

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