JOB REQUIREMENTS:

• Education

o College degree desired, preferably with a Healthcare or Life Science degree or equivalent experience

• Experience

o 4 + years of Clinical Research Associate (CRA) experience or equivalent preferred.
o 0-2 years of Clinical Trial Management (CTM) experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the role.
o Specific therapeutic experience may be required (e.g. infectious disease, oncology, etc.)

o In some regions, specific licensure may be required (e.g. Pharmacist, Registered Nurse, etc.)

• Skills/Competencies

o Strong written and verbal communication skills.
o Able to analyze information, set strategy and follow plan through completion.
o Fosters active exchange of information and ideas.
o Strong interpersonal skills: ability to establish and maintain strong and harmonious relationships with both internal and external customers.
o Represents the company externally as Company brand ambassador.
o Expert monitoring skills to independently conduct all types of site monitoring visits.
o Exceptional computer skills and ability to work across multiple technologies.
o Strong presentation skills.
o Comprehensive knowledge of GCP/ICH guidelines.
o Proficiency in medical terminology.
o Able to exercise judgment within defined procedures and practices and to determine appropriate action independently.
o Exceptional attention to detail.
o Superior problem-solving skills.
o Works successfully in a matrix environment.
o Ability to manage multiple vendors.
o Management of global studies preferred.
o Exceptional time management and organizational skills.

o Good documentation skills; good command of English and the local language in the area of activity (reading, writing, understanding).

• Capabilities

o Ability to work remotely, if required.
o Valid passport required in the case of international business travel.
o Between 10% to 20% travel, as needed.
The company will not accept unsolicited resumes from third-party vendors.

• Create and manage the Clinical Monitoring Plans (eg Clinical Monitoring Plan, Cohort Management Plan). Includes regular review (annual at minimum) and updates to the plan.
• Ensure project consistency and compliance within assigned projects, by following Company and/or sponsor SOPs, guidelines, and study plan documents.
• Develop and/or complete project specific training for clinical team.
• Collaborate with Lead Data Manager to develop CRF Completion Guidelines for sites.
• Perform User Acceptance Testing of EDC database prior to finalization.
• Oversee and track site preparations for activation, ensuring sites are fully trained and open to enroll within a timely manner following receipt of green light for IP release from SSU team. Includes but is not limited to: creation of template study documents, site file set up & delivery, SIV, EDC training, lab kit receipt etc.
• Supervise the ongoing site activities performed by assigned CRAs to ensure compliance with initial and updated project plans, study procedures and processes, SOPs, GCP.
• Serve as a site/CRA contact for protocol clarifications regarding subject enrolment.
• Responsible for the ongoing analysis of enrolment activities/trends, comparing these to contractual expectations. Escalate any deviations from expectations to PM/sponsor as appropriate.
• Develop suitable enrollment strategies alongside the PM and oversee the implementation of site level recruitment plans across the project to ensure recruitment targets are met.
• Monitor SDV status proactively and methodically, minimizing the accumulation of SDV backlog through deploying CRA resources effectively to monitor study data where needed.
• Oversee site visit scheduling and adjust where needed.
• Timely review of protocol deviations, action items, site queries/issues/escalations to identify trends and mitigate potential risks that may impact study data. Liaise with the PM as necessary to support the delivery of clean data in time for data cuts/ interim analyses / database locks.
• Oversee the collection of site information to support vendor set up, subsequent vendor training of sites, as well as facilitating the successful transfer of study material/samples/data to sites / vendors respectively.
• Provide guidance to CRAs to support the resolution of any missing samples/scans or data discrepancies between site and vendor.
• Act as first point of contact for sites/CRAs/sponsor/vendor to support resolution of any vendor related issues affecting the clinical operations.
• May be needed to oversee the IP inventory at the sites to ensure timely resupply and administration compliance.
• Maintain an overview of the essential documents collected from sites and conduct periodic reviews against site personnel log to ensure any updates to site teams are appropriately followed up for training & filing of essential documentation to TMF. Track the collection of other key site essential docs such as local lab normal ranges, calibration certificates, annual progress report submissions etc.
• Complete periodic eTMF QC in accordance with the respective project TMF plan. Communicate identified gaps to the team accordingly and oversee the timely resolution.
• Responsible for the management of the Clinical Monitoring scope of work under supervision of the PM, using both enrolment forecast and project budget/timelines to set site visit expectations and ensure these are adhered to.
• Track the completion of the monitoring team deliverables against the study budget, reporting these to the PM on a monthly basis.
• Use proactive site visit planning to forecast the CRA resource requirements on a study within the constraints of the study budget/timelines. Use these resource projections to ensure appropriate CRA staffing on a project.
• May review and approve weekly hours spent by CRAs completing contracted activities.
• Review of CTM/CRA resource utilization, with support from PM and finance.
• Responsible for CTMS compliance within the CM team for assigned project. Ensure that all Clinical team milestone dates are entered in a timely manner and all CRA site visits are booked into the system at least 3 months ahead of planned visit, where possible.
• Lead the delivery of clinical management activities completed by the CRA team, acting as a source of guidance and support.
• Serve as the main point of contact for the PM and sponsor, in regard to monitoring activities.
• May also have direct interactions with vendors as required.
• Attend and participate in project and department meetings (both internal and external), using the opportunity to present study status and discuss any risks/issues where required.
• Responsible for assuring the quality and timeliness of the clinical monitoring deliverables, including the identification and mitigation of risks, and the resolution of issues (including action Items, protocol deviations and queries).
• May conduct project co-monitoring visits to assure the quality of the clinical monitoring activities.
• May attend virtual PSSVs and/or SIVs with CRA(s) to ensure quality oversight and sponsor expectations are met.
• Timely CRA trip report review and escalation of pertinent issues when required. Includes review of new action items and deviations, as well as ensuring CRA filing of the visit report packet (confirmation letter, report, follow up letter).
• Contribute content to the study newsletter.
• May support PM in facilitating the tracking/payment of investigator fees.
• Conduct other activities as required for a given project.
• May assume CRA duties and responsibilities in exceptional circumstances.
• Maintain compliance with internal training requirements.
• Contribute content to CTM, CRA, and/or CTA training programs.
• Provide performance feedback to CRA team, PM, and Line Management.
• Deliver Clinical Monitoring portion of a bid defense presentation either in a virtual or face to face environment (as required by the business need).
• Complete weekly time and expense entry in compliance with Caidya T&E policy.