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The Site Management Lead (SML) provides operational expertise and leadership to multiple clinical operations teams, to ensure the effective and efficient delivery of all operational aspects of multiple studies through all phases of clinical study management. S/he does so in accordance with applicable Veristat Policies, Standard Operating Procedures (SOPs), conventions and instructions, as well as current Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and applicable local regulations.
As an SML You Will...
Assist with the coordination and management of site-related activities for assigned projects, with guidance from the Project Manager.
Working with the Project Manager, provide oversight and mentorship to Site Management Associate and Clinical Trial Assistant project teams, and assist in providing study-related training.
Coordinate & manage site deliverables from site start up activities to database lock, by supporting the Site Management team in the management of selected investigative sites with IRB/IEC/REB submissions, regulatory document collection and review, screening and enrollment, study maintenance and closeout.
Perform quality checks on regulatory and site essential documents, and lead site activation and green-light approval process.
Support the trial team to ensure trial timelines are being met and proactively inform the PM of corrective actions, as needed.
Support and/or interface with external vendors and clinical site personnel, as needed.
Provide input in the development of clinical trial related documents including but not limited to: protocols, case report forms, informed consents, conventions/timelines, monitoring plans, site reference manuals, pharmacy manuals, laboratory manuals, training materials, and site initiation visit slide presentation.
Oversee development of ISF and TMF binders, all recruitment materials, and any other recruitment tools.
Assist in ensuring audit readiness by ensuring the eTMF/TMF are up to date at all times, and participate in the QC process for reviewing the eTMF at regular intervals.
Maintain study specific tracking tools (via Clinical Trial Management System) and ensure they are current throughout the life cycle of the trial.
Provide study updates to PM and leadership team, escalate issues appropriately and oversee implementation of resolutions.
Ensure implementation of Veristat SOPs and study specific processes by project team.
Attend Project Meetings and teleconferences and provide department updates regarding study startup, enrollment, risks, etc.
Assist in preparation for audits and inspections; participate in inspections and in responding to any issues identified within the timeframe specified.
Experience + Requirements
Bachelor’s degree in a relevant field required; biological science, Pharmacy, Nursing, or related field preferred.
3 to 5 years in Clinical Operations or similar department required, with experience leading project teams to success.
SOCRA or ACRP certification and/or membership preferred.
Thorough knowledge of clinical operations, clinical development process, and ICH/GCP and regulatory environment.
Excellent communication skills and attention to detail within a fast-paced office environment required.
Willing and able to work well in a matrixed environment, across departments, across levels, amongst competing priorities and multiple stakeholders (both internally and externally).
Expert skills in Microsoft Word, Excel, Project, and PowerPoint required.
Proven clinical development experience in the operational aspects of clinical studies, including the ability to mentor, coach and train assigned team members.
Excellent oral and written communication skills in English (other languages a plus), to effectively support and manage exchanges with external customers.
Proficient knowledge of study specific therapeutic area to enable appropriate input to study documents (e.g., protocols, CRFs, EDC development).
Proficient in clinical systems including EDC, IVRS, CTMS, eTMF and other project management tools.
Ability to self-motivate, be a flexible team player, and work independently.