Clinical Data Team Lead(Clinical Data Manager) - Early Development Phase I

Pharmaceutical Product Development (PPD)

NC-Morrisville-Morrisville NC 3900 Paramou


Submission for the position: Clinical Data Team Lead(Clinical Data Manager) - Early Development Phase I - (Job Number: 174946)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 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 CDM PM’s to lead, create, monitor and close studies in a timely manner. This position also works with sites, clients, and other team members at 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 a lead data manager for one or more projects and a liaison to the PM and /or client as required.

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 an interdepartmental and client liaison for all DM study activities.

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

Monitors and analyzes study metrics and escalates per the organization’s risk management processes.

Participates in business development activities by assisting with bid preparation and representing data management at bid defense meetings, where required.

Assists with project forecasting of hours and identification of resource requirements.

Assists with the oversight of project budgets including identification of potential out of scope work and participation in the Contract Modification process.

Leads, high volume/highly complex studies.

Independently leads and delegates tasks to ensure timely completion of project activities to project timelines, quality and budget.

Mentors junior level staff on all associated tasks within a study.

Assists with administrative and financial oversight for allocated projects.

Communicates with management regarding all data management activities within their studies.

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 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 CDM PM’s to lead, create, monitor and close studies in a timely manner. This position also works with sites, clients, and other team members at 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 a lead data manager for one or more projects and a liaison to the PM and /or client as required.

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 an interdepartmental and client liaison for all DM study activities.

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

Monitors and analyzes study metrics and escalates per the organization’s risk management processes.

Participates in business development activities by assisting with bid preparation and representing data management at bid defense meetings, where required.

Assists with project forecasting of hours and identification of resource requirements.

Assists with the oversight of project budgets including identification of potential out of scope work and participation in the Contract Modification process.

Leads, high volume/highly complex studies.

Independently leads and delegates tasks to ensure timely completion of project activities to project timelines, quality and budget.

Mentors junior level staff on all associated tasks within a study.

Assists with administrative and financial oversight for allocated projects.

Communicates with management regarding all data management activities within their studies.

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 2 years).5 years required for Senior Clinical Data Team Lead. Years of experience relates to directly leading studies.

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 expectations

Ability to use interactive computer programs

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 work productively in both a team environment and independently as needed

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

Strong customer focus and excellent interpersonal skills.

Ability to direct and train study team

Ability to act as a study or department expert for DM processes

Ability to support project resourcing and project timeline planning and adherence to timelines

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 qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years).5 years required for Senior Clinical Data Team Lead. Years of experience relates to directly leading studies.

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 expectations

Ability to use interactive computer programs

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 work productively in both a team environment and independently as needed

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

Strong customer focus and excellent interpersonal skills.

Ability to direct and train study team

Ability to act as a study or department expert for DM processes

Ability to support project resourcing and project timeline planning and adherence to timelines

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: Clinical Data Team Lead(Clinical Data Manager) - Early Development Phase I - (Job Number: 174946)


2020-09-14 00:00:00


Apply to this job