TechData Service Company, LLC, is a recruiting and project services providing contract and full time resources to pharmaceutical, biotechnology, device, CRO, and related organizations. TechData Service Company works with most of the top pharmaceutical companies and several CROs in the U.S.
Our client is looking for a Lead Site Manager to lead the CRAs. THE SUCCESSFUL WORKER CAN WORK FROM ANY LOCATION.
Rates are negotiable. Our clients are in need of the following position below.
If you are interested in the roles then please contact Louis Pasquarello at firstname.lastname@example.org.
This person can live anywhere in the US. They will be an LSM so will only have 1 or 2 sites that are local to their home office. Workload is 1 to 3 trials depending on size (LSM oversees studies).
Therapeutic area preferred. Ophthalmology, dermatology, CNS, device, urology or women’s healthcare.
Lead and coordinate Regional Site Mangers (RSMs) for assigned studies by providing monitoring expertise and ensuring deliverables (protocol, monitoring plan, SOPs, regulations) are met on time. Function as a liaison and primary contact between RSMs and Clinical Development, Global Clinical Trial Management, Data Management, Global Patient Safety & Epidemiology, Global Clinical Supplies Management, GSMO Program Lead, Regional Operations Manager (ROM), clinical sites, and vendors.
In addition, the Principal Regional Site Manager holds other assignments, such as Lead Site Manager (LSM), Global Site Management Operations Subject Matter Expert (SME), CRO Monitoring Oversight Lead (CML) or any other project assigned by Global Site Management Operations management.
This is a regionally based position.
Main Areas of Responsibilities
• Manage monitoring activities to ensure deliverables are met by maintaining project metrics and status of deliverables. Proactively communicate issues, risks and staffing needs to Program Lead, RSMs and Clinical Trial Team. Assist Program Lead with RSM selection for outsourced trials.
• Act as a resource for RSMs to answer questions, provide guidance, and participate in co-monitor visits. Make sure RSMs are maintaining standards established by GSMO.
• Monitor quality of data in EDC along with RSMs, Data Management, GSMO Program Lead and Clinical Trial Team (CTT).
• Review completed Site Feasibility Questionnaires, Site Qualification Visit reports and maintains all tracking reports (SIV, IMV, RMV, COV) for GSMO Program Lead.
• Develop monitoring tools for project to ensure consistency such as Protocol Specific Monitoring Plan and amendments, report guidelines, checklists, tool kits, etc. Provide PSMP training and assist with GSMO orientation sessions as necessary.
• Conduct/assist with RSM teleconferences and deliver training and information as required. Attend team meetings and disseminate information as necessary.
• Collaborate with CTT and GSMO PL in review of study specific eCRFs, completion guidelines, etc.
• Act as Lead Site Manager, resource for RSMs and mentor for new Lead Site Managers.
• Contribute to process development, improvement and documents to drive consistency.
• Maintain monitoring portion of study portal for RSMs.
• Maintain knowledge of ICH/GCP, regulatory requirements, CLIENT'S SOPs, therapeutic area (protocol, amendments).
• May be responsible for monitoring 1 to 2 sites on assigned trial.