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Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings
resolution. Investigates and follows-up on findings as applicable.
Participates in investigator meetings as necessary. May help to identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
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Monitor investigator sites using a risk-based monitoring approach, applying root cause analysis (RCA), critical thinking, and problem-solving skills to identify site process gaps and implement appropriate corrective and preventive actions (CAPA).
Perform on-site and remote monitoring activities, including SDR, SDV, CRF review, and investigational product accountability, to ensure protocol compliance, subject safety, and data integrity.
Prepare monitoring reports, follow-up letters, and other study documentation in a timely manner using approved business writing standards. Escalate site issues and follow them through to resolution in collaboration with clinical management and the project team.
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