Clinical Data Team Lead(Clinical Data Manager) - Homebased in U.S

Submission for the position: Clinical Data Team Lead(Clinical Data Manager) - Homebased in U.S - (Job Number: 170970)

Home-based in the US.

PPD is a leading global contract research organization.At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

As a Clinical Data Team Lead, you will act as the lead data manager for one or more projects and serve as a liaison to the Project Manager and /or client as required. In addition, you will lead high volume/highly complex studies and assist with the oversight of project budgets including identification of out of scope work and participation in the Contract Modification process.

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry. Our scientists work together to accelerate pharmaceutical development for small molecules, biologics, and vaccines -allowing our clients to make faster decisions about their compounds.

Responsibilities:Ensures database accuracy according to departmental operating proceduresPerforms a QC review of the data and makes corrections to the DM databaseDevelops data validation manualDefines and tests databases and data validation systemRepresents Data Management in all cross functional meetings relating to the studyReviews data listings for consistency and accuracy of dataDevelops and maintains data management project documentation filesPerforms independent reviews of data management deliverables following documented guidelinesActs as an interdepartmental and sponsor liaison for all DM study activitiesProduces project-specific status reports for management and sponsorsMonitors study metricsAnalyzes and resolves discrepancies in data validation or other reportsPPD offers continued career advancement as a Clinical Data Team Lead, as well as management and specialized opportunities in other departments within PPD.

At PPD, we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk - our award winning training programs speak for themselves.

To learn how PPD can advance your career, apply now!

What To Expect NextWe look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview.

Home-based in the US.

PPD is a leading global contract research organization.At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

As a Clinical Data Team Lead, you will act as the lead data manager for one or more projects and serve as a liaison to the Project Manager and /or client as required. In addition, you will lead high volume/highly complex studies and assist with the oversight of project budgets including identification of out of scope work and participation in the Contract Modification process.

PPD Laboratories offers the most comprehensive set of laboratory services available in the industry. Our scientists work together to accelerate pharmaceutical development for small molecules, biologics, and vaccines -allowing our clients to make faster decisions about their compounds.

Responsibilities:Ensures database accuracy according to departmental operating proceduresPerforms a QC review of the data and makes corrections to the DM databaseDevelops data validation manualDefines and tests databases and data validation systemRepresents Data Management in all cross functional meetings relating to the studyReviews data listings for consistency and accuracy of dataDevelops and maintains data management project documentation filesPerforms independent reviews of data management deliverables following documented guidelinesActs as an interdepartmental and sponsor liaison for all DM study activitiesProduces project-specific status reports for management and sponsorsMonitors study metricsAnalyzes and resolves discrepancies in data validation or other reportsPPD offers continued career advancement as a Clinical Data Team Lead, as well as management and specialized opportunities in other departments within PPD.

At PPD, we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk - our award winning training programs speak for themselves.

To learn how PPD can advance your career, apply now!

What To Expect NextWe look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview.

Qualifications

Education and Experience:

Bachelor's degree OR certification in a related allied health profession from an appropriately accredited institution (i.e. RN, MT, PA, RPh, RT)3 years work experience in a professional environment, preferably within a clinical or medical data environment, including 2 years of data management experience or a combination of performance, education and prior directly related experience may be consideredEquivalent to the above requirements provided that the individual possesses the following knowledge, skills, and abilities to perform the job requirements satisfactorilyKnowledge, Skills and Abilities:

Knowledge of Oracle Clinical, Rave or other EDC systems is preferredAbility to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, SOPs and client expectationsStrong attention to detail and skill with numbersAbility to use interactive computer programsGood written and verbal communication skillsGood organizational and analytical/problem-solving skillsAbility to work productively with minimal supervisionAbility to maintain a high degree of confidentiality with clinical data and client's proprietary dataAbility to attain, maintain and apply a working knowledge of GCPs and applicable SOPsStrong customer focus and excellent interpersonal skillsAbility to work in a team environment and independently as neededAbility to train and direct study teamMust demonstrate good judgment in making decisionsAbility to travel to other locations as required or as business need dictatesMust be able to set and meet timelines or be able to recognize and schedule changes in response to project demandsAbility to identify potential out of scope activities to project and CDM management and to assist with the contract modification processStrong command of English language and grammarPPD 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 mannerAble to work upright and stationary for typical working hoursAbility to use and learn standard office equipment and technology with proficiencyAble to perform successfully under pressure while prioritizing and handling multiple projects or activitiesMay require travel (Recruiter will provide more details)*LI-BM1

Qualifications

Education and Experience:

Bachelor's degree OR certification in a related allied health profession from an appropriately accredited institution (i.e. RN, MT, PA, RPh, RT)3 years work experience in a professional environment, preferably within a clinical or medical data environment, including 2 years of data management experience or a combination of performance, education and prior directly related experience may be consideredEquivalent to the above requirements provided that the individual possesses the following knowledge, skills, and abilities to perform the job requirements satisfactorilyKnowledge, Skills and Abilities:

Knowledge of Oracle Clinical, Rave or other EDC systems is preferredAbility to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, SOPs and client expectationsStrong attention to detail and skill with numbersAbility to use interactive computer programsGood written and verbal communication skillsGood organizational and analytical/problem-solving skillsAbility to work productively with minimal supervisionAbility to maintain a high degree of confidentiality with clinical data and client's proprietary dataAbility to attain, maintain and apply a working knowledge of GCPs and applicable SOPsStrong customer focus and excellent interpersonal skillsAbility to work in a team environment and independently as neededAbility to train and direct study teamMust demonstrate good judgment in making decisionsAbility to travel to other locations as required or as business need dictatesMust be able to set and meet timelines or be able to recognize and schedule changes in response to project demandsAbility to identify potential out of scope activities to project and CDM management and to assist with the contract modification processStrong command of English language and grammarPPD 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 mannerAble to work upright and stationary for typical working hoursAbility to use and learn standard office equipment and technology with proficiencyAble to perform successfully under pressure while prioritizing and handling multiple projects or activitiesMay require travel (Recruiter will provide more details)*LI-BM1

Submission for the position: Clinical Data Team Lead(Clinical Data Manager) - Homebased in U.S - (Job Number: 170970)