Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there's no better place to grow your career than Advanced Clinical.
Works as a member of Clinical Management to direct and provide monitoring oversight for clinical trials, in accordance with SOPs and GCP/ICH regulations. Interacts with Clinical and Data Sciences teams, external service provider (ESP) personnel, Health Care Provides, investigators and study site staff to ensure understanding and adherence to monitoring processes and compliance with FDA and international regulations, GCPs and SOPs. Oversees Clinical transfer of regulatory obligations quality systems and inspection readiness preparations.
- Oversees clinical program/project compliance with clinical quality systems documentation including ePlatform systems and adherence to regulations, GCP, SOPs
- Collaborates with ESP and clinical project teams related to Oversight and clinical quality systems including ePlatform systems
- Responsible for implementation of the Oversight Plan for clinical trials
- Responsible for implementation of a risk based approach to the oversight process; including but not limited to assessment of risk; determination of oversight tasks to be conducted based on risk; development of Oversight Action Plan in collaboration with Supervisor and project team
- Responsible for oversight and management of trial risk based management (RBM) methodologies
- Identifies and escalates potential serious compliance issues, and develops or assists in the development and implementation of CAPAs.
- Conduct Accompanied Visits (OAVs) in accordance with the Oversight Plan and the RBM methodologies in place for the protocol and plans across projects
- Identifies and tracks issues and oversees ESP staff to bring these issues to appropriate resolution
- Conducts reviews of subject and aggregate study data; and escalates issues to study team for resolution, as necessary
- Manages review of ESP Monitoring Reports and/or telephone contact reports including identification of reports to be reviewed, conduct of the review and verification of identified issues as assigned
- Develops the Trial Master File Plan (eTMF) and manages the implementation and execution of the plan for assigned trials
- Collaborates with the eTMF Business Admin to execute study wizards and define study structure within eTMF
- Confirms and manages timelines for finalization or return and archival of the Trial Master File per the eTMF Plan and any applicable SOW requirements
- Provides oversight of ESP for quality & contemporaneous state of the Trial Master File for assigned trials according to the eTMF Plan
- Conducts review of the Trial Master File for assigned trials according to the eTMF Plan including identification of sections/documents for review and timeliness of filing
- Identifies and tracks TMF issues; and collaborates with ESP to ensure and verify resolution of identified issues
- Manages CAPA activities related to monitoring, Trial Master File, and other clinical activities as assigned. Conducts follow-up activities to promote adherence to CAPA plans, apply continuous improvement and implementation of lessons learned
- Conducts CAPA Management & Issue resolution though maintenance of appropriate documentation; ensure and verify resolution of identified issues, etc.
- Provides Risk Base Monitoring/eTMF system training for ESP users
- Manages review and approval of CVs for proposed ESP CRAs for assigned trials
- Supports and orchestrates the Perpetual Compliance (PC) activities for assigned project; Responsible to assess the status of PC/IR compliance on an ongoing basis during the project in collaboration with Supervisor and project team; Collaborate with CQM and the Clinical Team to support the IR team (ESP, CTL, CM, and functional areas) including leading/participating in IR team meetings, as necessary
- Maintains documentation for oversight tasks as conducted per Oversight Action Plan (i.e. total Oversight Accompanied visits conducted, total monitoring Reports reviewed, etc.) and presents findings to ESP staff routinely
- Actively participates in project team meetings and provides updates on current state of Oversight, as assigned
- Reviews/provides input to and/or authors other project plans (i.e. CMP) and documents, as assigned. Ensures consistency is maintained in study documentation (i.e. CMP and data plan)
- Contributes to site selection activities as assigned
- Reviews tables and study reports as assigned
- May provide Oversight updates/training to ESP as assigned
- Develops project related procedures based on the project quality systems used (i.e. remote data review), as required
- Performs other Clinical Management duties as assigned
What's in it for you?
- Knowledge: Comprehensive knowledge of clinical trial management, transfer of sponsor obligations and the drug development process, roles and responsibilities of individuals within the project team, SOPs and GCP/ICH regulations; good working knowledge of contract research organizations, outsourcing, and evaluation of work performed against vendor Statement of Work.
- Skills: Strong communication, organization, planning and analytical skills, ability to assess and manage risk, problem solving and robust people management and soft skills. Demonstrated experience working with the Microsoft suite of programs (Word, Excel, PowerPoint, Outlook). Good understanding of clinical trial related software including proficiency in managing and integration of current eTechnologies (i.e., eConsent, eSource, eCRF, IRT, eTMF, etc.). Prefer vendor management experience; experience in formulation and writing of project plans; and ability to develop project related procedures based on the project quality systems used (i.e. remote date review).
- Required: Bachelor's degree or registered nurse. Minimum of 5 years in the pharmaceutical industry and 5 years of clinical trial monitoring, auditing or monitoring oversight experience.
Advanced Group offers competitive compensation, comprehensive benefits packages, and a flexible work environment designed to help our team members and their families stay healthy, meet their financial goals, and generally thrive in and beyond work. Visit the links below to discover all that Advanced Group has to offer: Our Culture:
https://careers.advancedgroup.com/embrace-our-culture Career Development Opportunities:
https://careers.advancedgroup.com/realize-your-potential Community Programs:
At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Group in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience.
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.
This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.