Senior Clinical Data Associate - Homebased in the U.S

Submission for the position: Senior Clinical Data Associate - Homebased in the U.S - (Job Number: 182082)

Homebased in the U.S

Full Time Regular w/ Benefits

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 Sr Clin Data Assoc, you will help ensure the highest quality and effectiveness of clinical trial data. You will work directly with team members to clean and edit clinical trial data in a timely manner. You will also work with EDC(electronic Data Capture) systems and process study specific reports and data listings.

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:

Performs all aspects of the data cleaning process, with minimal supervision, in accordance with GCP and SOPs/WPDs in order to assess the safety and efficacy of investigational products and/or medical devices.

Essential Functions

Supports the setup of study activities such as database design, testing of data entry screens, and Data Validation Manual (DVM) creation, as required.

Reviews data listings for accuracy and consistency of data. •Acts as point person and subject matter expert for specialized study-specific processes.

Generates, tracks and resolves data clarifications and queries and makes changes to the clinical database as required.

Contributes to the improvement of data management processes on a global level.

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

Provides training and work direction to junior staff as required.

Homebased in the U.S

Full Time Regular w/ Benefits

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 Sr Clin Data Assoc, you will help ensure the highest quality and effectiveness of clinical trial data. You will work directly with team members to clean and edit clinical trial data in a timely manner. You will also work with EDC(electronic Data Capture) systems and process study specific reports and data listings.

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:

Performs all aspects of the data cleaning process, with minimal supervision, in accordance with GCP and SOPs/WPDs in order to assess the safety and efficacy of investigational products and/or medical devices.

Essential Functions

Supports the setup of study activities such as database design, testing of data entry screens, and Data Validation Manual (DVM) creation, as required.

Reviews data listings for accuracy and consistency of data. •Acts as point person and subject matter expert for specialized study-specific processes.

Generates, tracks and resolves data clarifications and queries and makes changes to the clinical database as required.

Contributes to the improvement of data management processes on a global level.

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

Provides training and work direction to junior staff as required.

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 0 to 2 years).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 and Abilities:

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

Strong attention to detail and skill with numbers

Good written and verbal communication skills

Good analytical/problem-solving skills

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•Must be able to set and meet timelines or be able to negotiate schedule changes in response to project demands

Knowledge of medical/clinical terminology

Understands project protocol and DVM

Proven ability in achieving applicable technical competencies per the DM competency grid

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 ideaswith diverse groups of peoplein a comprehensible and reasonable manner.

Able to work upright and stationary for typical working hours.

Ability to use and learnstandard office equipment andtechnologywith proficiency.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

May require travel. 5-10% 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 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 0 to 2 years).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 and Abilities:

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

Strong attention to detail and skill with numbers

Good written and verbal communication skills

Good analytical/problem-solving skills

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•Must be able to set and meet timelines or be able to negotiate schedule changes in response to project demands

Knowledge of medical/clinical terminology

Understands project protocol and DVM

Proven ability in achieving applicable technical competencies per the DM competency grid

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 ideaswith diverse groups of peoplein a comprehensible and reasonable manner.

Able to work upright and stationary for typical working hours.

Ability to use and learnstandard office equipment andtechnologywith proficiency.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

May require travel. 5-10% 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: Senior Clinical Data Associate - Homebased in the U.S - (Job Number: 182082)