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3 months ago
Company Overview
At Allergan, our commitment is to innovate and provide groundbreaking medical solutions that address significant health challenges today and in the future. We aim to make a profound difference in the lives of individuals across various therapeutic domains, including immunology, oncology, neuroscience, and eye care, alongside our offerings in the Allergan Aesthetics portfolio. For further insights about Allergan, please visit our website.
Position Overview
The role is pivotal in facilitating Allergan's evolution into a premier R&D entity, focusing on the effective execution of protocol-level responsibilities related to Clinical Study Management (CSM) throughout the lifecycle of clinical trials.
Key Responsibilities:
- Oversee the execution of protocol-level CSM responsibilities for designated sites/studies, ensuring comprehensive management of study initiation, implementation, and closure. This includes site monitoring visits, evaluations, selection, activation, and the preparation of close-out reports. Proactively identify potential site-related challenges that may impact timelines and devise alternative strategies.
- Maintain and update clinical trial management systems with all site-specific data. Provide expertise in local regulatory and legal requirements, ensuring timely financial transactions for assigned sites/studies in accordance with clinical study agreements and local regulations.
- Ensure compliance with federal and local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Allergan Standard Operating Procedures (SOPs), and quality standards in clinical research. Stay informed about evolving local regulations and guidelines.
- Prepare assigned sites for audits and inspections, advising on pre-audit activities related to GCP compliance. Manage site audits/inspections and contribute to the development of Corrective and Preventive Actions (CAPA).
- Mentor and guide Clinical Research Associates (CRAs), contributing to their professional development and providing support across various aspects of their roles.
- Act as the primary contact for Contract Research Organizations (CROs) for assigned studies, and may participate in or lead global/local initiatives and task forces as directed by management.
- Identify training needs and standardize training solutions for CSM monitors globally, ensuring a consistent approach to onboarding and integrating lessons learned into training materials.
- Serve as a key point of contact for assigned studies, updating relevant systems with country-level information, including planning timelines and assignments.
- Act as a Global Representative for one or multiple studies, collaborating with key stakeholders to ensure strategic and tactical success throughout the study lifecycle.
- Conduct remote data reviews for assigned sites/studies in accordance with the Integrated Data Review Plan (IDRP) and Monitoring Plan, providing ongoing feedback based on site performance and fostering professional relationships with peers and site monitors.
Qualifications:
- Education: Bachelor’s degree or equivalent in a health-related field (e.g., Medical, Scientific, Nursing, Pharmacy) is preferred.
- Experience: A minimum of 5 years in site monitoring.
- Skills: Strong analytical and critical thinking abilities to assess complex issues from various perspectives and facilitate informed decision-making.
- Interpersonal Skills: Excellent communication skills, with the ability to convey information clearly and adapt to changing requirements. A proactive and positive team player is essential.
- Organizational Skills: Strong planning and organizational capabilities, with a high degree of flexibility in a dynamic environment with competing priorities.
- Integrity: Demonstrated commitment to business ethics and integrity.
Additional Information
Allergan is an equal opportunity employer dedicated to fostering an inclusive environment. We are committed to employing qualified individuals without discrimination based on race, color, religion, national origin, age, sex, disability, or any other legally protected status.
