PPD Hiring For RSM (LEVEL I) – C at Bengaluru, Karnataka Full Time

Summarized Purpose:
Performs site management and other related activities on assigned project(s) in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and PPD SOPs. Reviews study data from various sources remotely. Develops collaborative relationships with investigational sites and other stakeholders as applicable. May contact the study sites to collect study documentation, resolves issues and requests outstanding information if applicable. Detailed tasks and responsibilities assigned to RSMCentral or RSM-Local positions are outlined in the task matrix.

Job Qualification

According to the specific role (Central or Local) may coordinate, oversee and complete assigned trial activities detailed on the task matrix, including but not limited to the following:

• Develops and maintains a close and collaborative communication with the site staff. Actively discusses protocol conduction, enrollment rates and strategies, open issues, EDC completion and queries, as well as any other topic or indicator associated to project status and site performance.
• Completes/tracks/follows up ETRTR for subject data present in the EDC and other applicable systems, according to the study-specific guidelines. Raises manual queries in EDC when applicable.
• Remotely reviews study logs as deemed necessary.
• Conducts and documents site management calls/contacts according to the monitoring plan. Participates in investigator meetings. Investigates and followsup on centralized monitoring findings.
• Evaluates PI oversight (e.g., protocol adherence), subject safety and study processes to assess site’s ability to conduct study on a regular basis. Conducts remote investigations into site performance using a risk based monitoring approach: applying root cause analysis (RCA), critical thinking and problemsolving skills to help identify site process failure and work on corrective/preventive actions to bring the site into compliance and decrease risk.
• Provides refresher training, follows up on outstanding administrative needs (e.g., outstanding/updated regulatory documents), assists with regulatory reviews, as requested, etc.
• Reviews ad-hoc clinical listings review, tracks and trends violations and deviations, site status, enrollment, CRF status and SAE follow up.
• Provides trial status tracking and progress update reports to study manager.
• Participates in the investigator payment process, if applicable.
• Liaises with internal staff to promptly collect documents, review data points and findings from EDC and file reviews, etc.
• Assists in ensuring audit ready files and complying with CTMS and eTMF data stewardship. Contributes to company, client, and federal/local regulatory requirements/audit responses.
• Detailed task assignment and responsibilities are outlined on the task matrix, as well as any applicable protocol guidelines.

Diversity Statement

PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.