If you are seeking a career where you can truly make a difference in the lives of others, working closely together with the top minds in the pharmaceutical Industry, then here is your chance. We are hiring a "Study Start-Up Manager" to work closely with our client, a leading pharmaceutical company.
The Study Start-Up Manager (SSU Manager) is responsible at country level for managing and conducting start-up activities in compliance with the AZ procedures, documents, local and international guidelines such as ICH - GCP and relevant regulations.
The SSU Manager will prepare, review, track and manage site regulatory documentation at country and site level, and will maintain, review and report on site performance metrics.
The SSU manager works in close collaboration with the CRAs and the Local Study Team/Local Study Associate Director to ensure that study start-up activities and milestones are achieved in a timely and efficient manner.
• Contribute to ensure that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
• Accountable for study start-up and regulatory maintenance being in charge with collection, preparation, review and tracking of documents for the application process;
• Accountable for submission of proper application/documents to Regulatory Authorities and/or IEC/IRB during start-up period.
• Actively participates in Local Study Team (LST) meetings.
• Update CTMS and other systems with data from study sites as per required timelines during the start-up period.
• Follow up on outstanding actions with study sites during start-up period to ensure resolution in a timely manner.
• Ensure timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, AZ SOPs and local requirements. Support QC checks performed by LSAD or delegate to ensure that all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with AZ SOPs.
• Provide regular information to Line Managers at country level on study and planned study milestones/key issues during the start-up period.
• Provide feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
• Support SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management.
Upon local decision, additional responsibilities may include:
• Prepare, review and negotiate contracts with investigational sites being the primary point of contact for investigational sites to ensure the contracts are fully executed
• Support site selection process by identifying and assessing potential sites/investigators
• Accountable for continuing submission of proper application/documents to IEC/IRB and to Regulatory Authorities for the duration of the study.
• Assist in initial forecasting for budget, study materials and drug supplies. Plan applicable local drug activities (local purchase or reimbursement)
Required experience and qualifications
• Bachelor degree in related discipline, preferably in life science, or equivalent qualification.
• Good knowledge of international guidelines ICH-GCP as well as relevant local regulations, basic knowledge of GMP/GDP
• Basic understanding of drug development process
• Good collaboration and interpersonal skills.
• Good verbal and written communication skills.
• Excellent attention to details.
• Excellent understanding of Clinical Study Management and study start-up
• Good negotiation skills.
• Good ability to learn and to adapt to work with IT systems.
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.