Central Review Manager

Performs review of clinical monitoring visit reports for allocated projects ensuring consistency across protocols and/or

regions and escalates any protocol, site, and/or CRA issues or trends noted during the report review process to CTM.

Liaises with clinical monitoring staff for prompt trip report review submission and approval as per the stipulated timelines

of PPD and/or the Sponsor. Plays an active role on the project team to help ensure compliance with monitoring visit report

expectations. Reviews and customizes the Monitoring Report Templates for allocated projects. Evaluates PI oversight

(e.g., protocol adherence), subject safety and study processes in order to assess site’s ability to conduct study, as

ascertained from information noted in monitoring visit reports and associated electronic data systems. Attends applicable

internal Project meetings. Provides input of forecast estimates for report review activities. Provides trial MVR status

tracking and progress update reports to team as required. Contributes to company, client, and federal/local regulatory

requirements/audit responses as needed. May perform support activities to the team as agreed on allocated projects.

Performs review of clinical monitoring visit reports for allocated projects ensuring consistency across protocols and/or

regions and escalates any protocol, site, and/or CRA issues or trends noted during the report review process to CTM.

Liaises with clinical monitoring staff for prompt trip report review submission and approval as per the stipulated timelines

of PPD and/or the Sponsor. Plays an active role on the project team to help ensure compliance with monitoring visit report

expectations. Reviews and customizes the Monitoring Report Templates for allocated projects. Evaluates PI oversight

(e.g., protocol adherence), subject safety and study processes in order to assess site’s ability to conduct study, as

ascertained from information noted in monitoring visit reports and associated electronic data systems. Attends applicable

internal Project meetings. Provides input of forecast estimates for report review activities. Provides trial MVR status

tracking and progress update reports to team as required. Contributes to company, client, and federal/local regulatory

requirements/audit responses as needed. May perform support activities to the team as agreed on allocated projects.

Education and Experience: • Bachelor’s Degree in a life science-related field or relevant/equivalent combination of

education, training, and experience that provides the individual with the required knowledge, skills, and abilities. •

Prior clinical research experience with a minimum of 2 years on site clinical monitoring. 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: Good therapeutic area

knowledge and understanding of medical terminology by virtue of past training of a CRA Ability to attain and maintain a

working knowledge of FDA and/or local country regulation and guidelines, ICH GCPs and PPD procedural documents

Ability to successfully complete PPD’s Clinical Foundation Training Program (CFP) Highly effective oral and written

communication skills with the ability to communicate effectively with project team members Excellent organizational and

time management skills Ability to work in a team or independently or as home based, as required Ability to write clinical

monitoring visit reports, review or approve them and interpret the information captured in clinical monitoring visit reports

Ability to extract pertinent information from protocols, electronic study data systems, CTMS, dashboards and assess risk

at site level through interpretation of all these data Excellent English language and grammar skills Ability to mentor junior

team members, as needed.

Education and Experience: • Bachelor’s Degree in a life science-related field or relevant/equivalent combination of

education, training, and experience that provides the individual with the required knowledge, skills, and abilities. •

Prior clinical research experience with a minimum of 2 years on site clinical monitoring. 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: Good therapeutic area

knowledge and understanding of medical terminology by virtue of past training of a CRA Ability to attain and maintain a

working knowledge of FDA and/or local country regulation and guidelines, ICH GCPs and PPD procedural documents

Ability to successfully complete PPD’s Clinical Foundation Training Program (CFP) Highly effective oral and written

communication skills with the ability to communicate effectively with project team members Excellent organizational and

time management skills Ability to work in a team or independently or as home based, as required Ability to write clinical

monitoring visit reports, review or approve them and interpret the information captured in clinical monitoring visit reports

Ability to extract pertinent information from protocols, electronic study data systems, CTMS, dashboards and assess risk

at site level through interpretation of all these data Excellent English language and grammar skills Ability to mentor junior

team members, as needed.