Overview
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.
Responsibilities
The Global Study Start-Up Lead is responsible to advance study start-up and regulatory activities by understanding the client objectives and assist in the development of the plan for country and site activation. The GSSU Lead responsible for managing and/or performing the regulatory start up and maintenance function, including the preparation, review, and overall management of submissions to regulatory authorities and ethics committees. The GSSU Lead is a contact point for client matters related to study start-up/product approval requirements and must be able to communicate issues effectively to the client, clinical team and Project Manager.
- Coordinates with BD and/or PM, as necessary, to transition awarded projects to Clinical Operations
- Leads study start-up activities and provides updates during client and internal team meetings.
- Including participation in Pre-KOM and/or KOM
- Leads site activation forecasting/projection activities with the input of the local associates.
- Oversee the execution of Start Up and/or Maintenance for assigned projects in accordance with the agreed Regulatory/SU strategy.
- Reviews program or study specifics to define project scope, timelines, and deliverables from award through project initiation and maintains/monitors throughout.
- Develops draft start up plan aligned with the SOW that clarifies study specific tasks, general timelines, and processes related to overall study start up and continued maintenance activities
- Initiates appropriate systems set up of awarded project, (CTMS/tracking, etc.)
- Creates initial Master Level Regulatory Pack
- Reviews Master ICF to ensure compliance with ICH-GCP Guidelines
- Assists PM to generate Master ICF in compliance with ICH-GCP, if applicable
- Initiates and Oversees country specialists review of Master ICF for compliance with local regulations
- Manages Study level translations
- Customizes Study Start Up Plan, clarifying study specific tasks, general timelines, and processes related to overall study start up and continued maintenance activities
- Lead day to day project activities for a team of start-up specialists
- Liaise with other project team members to ensure cohesive and clear project performance and expectation (including but not limited to TMF Manager, PM, and CTL)
- Coordinates with BD, PM, and/or Contracting, as necessary, to transition awarded projects to Clinical Operations
- Creates study specific templates
- Including but not limited to, review checklists, Regulatory Tracker (if applicable), Financial Disclosure, FDA Form 1572/Investigator Agreement, RDQC and IPRF, if applicable.
- Leads multidisciplinary project teams related to study start-up activities, including internal team members and external subcontractors and vendors (contracts, external CRO for CA Submissions/Site Start Up).
- Ensure collaboration across GSSU, including communication with countries, to successfully deliver the agreed project scope in compliance with the SU Plan.
- Initiates and oversees start up and maintenance project and performance tracking and metrics through project initiation:
- Implements risk mitigation actions
- Implements corrective actions as needed to maintain project performance
- Ensures quality reviews occur at key points with the participation of the appropriate personnel
- Ensures project deliverables comply with corporate standards and quality guidelines
- Monitors the project plans regularly for changes to the critical path and milestones, identifies other issues and ensures the change control process is followed.
- Participates in regular status meetings with the project team, reviewing project schedule, risks, issues and outstanding action items. Disseminates appropriate project information to all team members and Clinical Director on a regular basis
- Contributes to the Lessons Learned Report, with inputs from team members, at the completion of major project milestones.
- Regularly reviews project expectations, as well as baselined and approved project plans to ensure that all assumptions are still valid.
- Provides project related study start up and maintenance realization, as applicable.
- Recognizes change in or out of scope activities and ensures project management is notified and assists where needed with change order review.
- Assists with preparing, review and implementation of Change Orders for Amendment activities, not captured in initial budget
- Oversees and/or manages the collection of essential documents including but not limited to investigator qualifications and study related approvals as well as any other study specific required documents in accordance with ICH/GCP guidelines for site activation
- Oversees and/or manages tracking various key information and details, including but not limited to study level templates and regulatory documents, site regulatory documents, submission/approval, CA/EC queries (as applicable), and overall site status through life of study.
- Facilitates the registration of and maintenance of ongoing updates for clinicaltrials.gov, if task delegated to Advanced Clinical by Sponsor.
- Review pertinent regulations and guidance to develop proactive solutions to regulatory submissions issues and challenges
- Provide advice and guidance to internal and external team members to ensure compliance with applicable regulations and requirements
- Prepare for and participate in, internal or external audits/inspections.
- Including producing documentation as requested, as well as completing any activities that may be required due to a corrective action plan.
- Support Regional Manager in the development and/presentation of study start up training materials and SOPs, as needed.
- Ensures compliance with all applicable corporate and client policies and standards.
- Assist with presentations/training to clients, colleagues and professional bodies, as required.
- Assist with collection and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
- Assist in developing long standing relationships with customers
Qualifications
- Bachelor's Degree (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or relevant clinical other equivalent experience
- Minimum of 5 year of experience in a Clinical Research environment, focusing on Start Up
- Understanding of regulatory and submission processes in many different countries
- Ability to work to tight deadlines
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Strong organizational and planning skills
- Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located
- Ability to work independently in a fast-paced environment with a sense of urgency to match the pace
- Good leadership skills, with ability to motivate
- Understanding of study financial management
- Excellent written and verbal communication, fluent in English
- Occasional travel may be required
This job description is a summary. It is not intended to be comprehensive in detail. Individuals with this job title will be expected to perform according to their individual goals and evaluations in addition to this job description and all applicable standards (SOPs, manuals, code of conduct, laws, regulations, etc.).
What's in it for you? 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:
For a complete list of all of our job openings, please visit Advanced Group's career site here.
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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
