Covance gives you the best two-for-one opportunity for career growth. Who doesn’t want twice the perks? Working at Covance—one of the largest FSP CROs—and partnering with one sponsor with a dedicated therapeutic focus. You can have it all!
As a Covance employee dedicated to an FSP project, you will bring your specialized discipline to a core team working directly with one sponsor. Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance, Covance has an FSP opportunity to match your area of expertise.
You will enjoy the best of both worlds—all the benefits that come along with Covance’s Energizing Purpose, Exceptional People and Extraordinary Potential combined with working exclusively with one sponsor and this also comes with the benefit of bringing your strong therapeutic experience to allow your expertise to shine through.
Covance’s FSP model is flexible and scalable. Our teams are collaborative and proactive – a great place for you to continue honing your therapeutic skills and growing and excelling in new and exciting research.
Covance’s reach is global – extending to 60+ countries making us one of the largest FSP CROs. No matter where you are located on the globe, we have an FSP opportunity for you.
The Study Lead Monitor is responsible for overseeing all operational aspects of Monitoring and Site Management activities for the assigned Phase II-IV clinical trials for our client’s Global Clinical Development and Global Medical Affairs.
- Advisor to Study Team as expert in all operational aspects of conducting a clinical trial
- Verifies study processes and expectations correspond to the practicality of conducting the trial from the operational perspective, from study feasibility to study close out.
- Leads and manages the assigned Country Lead Monitors (CLMs) and CRAs globally, overseeing the operational conduct and quality oversight of the study from the global perspective.
- Reviews Country Monthly Reports, tracks operational study activities and progress, proactively identifies issues and escalates appropriately to see that timely corrective and preventive actions are taken. Consolidates Country Monthly Reports for Study Manager.
- Supports the Study Team Monitor in operational feasibility process and organization of the feedback from the countries
- Collaborates with Site Management Organization to develop Monitoring and Site Management component of the Operational Quality Oversight Plan and, if required, Data Verification Initiatives.
- Conducts co-monitoring visits and reviews Periodic Monitoring Visit Reports according to the Operational Quality Oversight Plan. Is an active member of the Fraud & Misconduct Team and/or Inspection Team, if applicable.
- Responsible and accountable for developing the study specific Monitor Training Plan and Investigator Site Training Plan. Obtains requisite functional and legal/compliance approvals and coordinates activities related to multi-center Monitor and Investigator Site Training meetings. Accountable for developing Monitor Training materials, ensuring study specific training of Monitors, training new Monitors to the study and reviewing and approving training content changes. Develops Investigator and Site staff training material for functional and operational study activities. Makes presentations as assigned at Investigator Site and/or Monitor Training as assigned.
- Responsible and accountable for developing the Study Monitoring Plan, Enrollment plan and determining Investigator delegation responsibilities for the study and obtains requisite functional approvals. Develops training material and training plan to see that all Monitors assigned to the study have a thorough understanding of the Monitoring Plan and study expectations.
- Contributes to the protocol, study plan and other operational plans development with regard to its monitoring operational aspects
- Works in close collaboration with Study Data Manager (SDM) to oversee consistent monitoring and data management objectives for the trial. Member of the Study Data Acquisition and Management Package Development Team (SDAMP-DT) and works closely with the EDC Developer in developing the eCRF, edit checks and eCRF instructions. Coordinates User Acceptance Testing and system access for Monitors and Investigator Site Staff. In partnership with SDM, tracks and manages patient data cleaning process to oversee continuous and current flow of data cleaning.
- Above responsibilities are applicable for all internally monitored clinical trials.
- For outsourced trials, the SLM is the primary contact with CLMs, CHSM and Country Medical Directors, verifies applicable information is cascaded in a timely manner and verifies required country reviews of applicable documentation.
In addition, the SLM will also be responsible for:
- Reviews study specific Monitor and Investigator Site Staff Training Plans and Investigator Meeting Approval Forms, obtaining requisite functional and legal/compliance approval.
- Reviews Study Monitoring Plan, the relevant CRO plans and verifies plan is consistent with client’s expectations.
- Oversees Operational Quality Oversight Plan by conducting co-monitoring visits, overseeing co-monitoring visits, reviewing Monitoring Visit Reports, etc. as defined in the Operational Quality Oversight Plan. Escalates operational issues or potential issues to StM as applicable.
- Leads and coordinates assigned Country Lead Monitors (CLM)
- Bachelor’s degree or equivalent with 7 years of relevant Healthcare experience and 5 years of direct monitoring experience in the Pharmaceutical Industry.
- Sr.CTL or CTL with monitoring exp.
- Responsible for collaborating with study lead and study team. Some Operational dotted line reporting but mostly Project Management. Represents the global monitoring team – must have global project leadership experience.
- Must have experience with experience with ePRO, DCT components like wearable, medical device ,e-Consent