Clin Data Team Lead

Home-Based in the U.S.

About PPD:

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.

About the Department:

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.

About the Position:

As a Clinical Data Team Lead, you will help ensure the highest quality of data and effectiveness of clinical trail 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, clients, and other team members at PPD.

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 wellbeing of our employees.

Summarized Purpose:

Acts as the lead data manager for one or more projects or to provide support to the lead data manager. May lead all data management activities for individual, limited volume/complexity studies with support from senior team members. Acts as an interdepartmental and client liaison for all DM study activities.

Essential Functions:

Applies relevant components of the project protocol to daily tasks and directs others on how to apply to their daily tasks. Acts as a liaison to the PM and/or client as required and communicates with management regarding all data management (DM) activities within their studies. Develops and maintains data management project documentation files; performs independent reviews of data management deliverables following documented CDM guidelines. Develops and delivers study specific training for DM project staff. Produces project-specific status reports for management, PM and/or clients on a regular basis. Monitors study metrics.May participate in business development activities by assisting with bid preparation and/or representing data management at bid defense meetings, where required. Assists with project forecasting of hours and identification of resource requirements and identifies potential out of scope activities to Project Managers and management and assists with the Contract Modification process. May mentor junior level staff on all associated tasks within a study. Assists with the administrative and financial management of allocated projects. Performs all assigned data management activities independently and efficiently, with attention to quality.Home-Based in the U.S.

About PPD:

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.

About the Department:

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.

About the Position:

As a Clinical Data Team Lead, you will help ensure the highest quality of data and effectiveness of clinical trail 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, clients, and other team members at PPD.

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 wellbeing of our employees.

Summarized Purpose:

Acts as the lead data manager for one or more projects or to provide support to the lead data manager. May lead all data management activities for individual, limited volume/complexity studies with support from senior team members. Acts as an interdepartmental and client liaison for all DM study activities.

Essential Functions:

Applies relevant components of the project protocol to daily tasks and directs others on how to apply to their daily tasks. Acts as a liaison to the PM and/or client as required and communicates with management regarding all data management (DM) activities within their studies. Develops and maintains data management project documentation files; performs independent reviews of data management deliverables following documented CDM guidelines. Develops and delivers study specific training for DM project staff. Produces project-specific status reports for management, PM and/or clients on a regular basis. Monitors study metrics.May participate in business development activities by assisting with bid preparation and/or representing data management at bid defense meetings, where required. Assists with project forecasting of hours and identification of resource requirements and identifies potential out of scope activities to Project Managers and management and assists with the Contract Modification process. May mentor junior level staff on all associated tasks within a study. Assists with the administrative and financial management of allocated projects. Performs all assigned data management activities independently and efficiently, with attention to quality.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 2 years).

Additional years of experience may qualify for Sr CDTL(5 )Experience should be relevant to leading CDM studies and activities.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:

Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, SOPs and client expectationsAbility to use interactive computer programsGood written/ verbal communication skills with a strong command of English language and grammar; good organizational, analytical/problem solving skills and attention to detailAbility to work productively with minimal supervisionAbility to maintain a high degree of confidentiality with clinical data and client's proprietary dataStrong customer focus and excellent interpersonal skillsProven flexibility and adaptabilityAbility to work in a team environment and independently as neededAbility to train and direct study teamAbility to set and meet timelines or be able to recognize and schedule changes in response to project demands

Management Role:

No management responsibility

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.

*LI-BM1

Tags: Clinical Data Manager, Senior Clinical Data Manager, Data Team Lead, Lead Clinical Data Manager, Lead Data Manager, Project Data Manager, Senior Project Data Manager,

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 2 years).

Additional years of experience may qualify for Sr CDTL(5 )Experience should be relevant to leading CDM studies and activities.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:

Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, SOPs and client expectationsAbility to use interactive computer programsGood written/ verbal communication skills with a strong command of English language and grammar; good organizational, analytical/problem solving skills and attention to detailAbility to work productively with minimal supervisionAbility to maintain a high degree of confidentiality with clinical data and client's proprietary dataStrong customer focus and excellent interpersonal skillsProven flexibility and adaptabilityAbility to work in a team environment and independently as neededAbility to train and direct study teamAbility to set and meet timelines or be able to recognize and schedule changes in response to project demands

Management Role:

No management responsibility

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.

*LI-BM1

Tags: Clinical Data Manager, Senior Clinical Data Manager, Data Team Lead, Lead Clinical Data Manager, Lead Data Manager, Project Data Manager, Senior Project Data Manager,