Abbott Clinical Trials Manager in San Diego, California
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At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.
We have an exciting opportunity for a Clinical Trials Manager within our Abbott Rapid Diagnostics business located at San Diego, CA . In this role, you will provides guidance and support for clinical operations for assigned studies provides guidance and support for clinical operations for assigned studies including project planning, budget, resource management and contract research organization management (as applicable) to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines and company goals.
Abbott Rapid Diagnostics (formerly Alere) is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.
Collaborate with GBU leaders and cross-functional stakeholders from R&D, regulatory affairs, biostatistics, and marketing and with external investigators to develop clinical strategies, objectives and study designs for validation of new Tox products in support of regulatory submissions globally.
Provide comprehensive support of all operational aspects of clinical trials for which he/she is responsible for, including the review and approval of protocols and study-related documents (e.g., Regulatory Binder, Work Instructions, CRF Completion Guidelines, etc.)
Effectively lead the operational clinical team for assigned studies and delegate appropriate tasks, assignments, and responsibilities to subordinates.
Develop and administer budgets, schedules and performance requirements for assigned studies.
Oversee the successful and efficient execution of assigned studies from study start up to study close out.
Ensure clinical operational study team members are aligned with the project objectives.
Identify, communicate, and find resolutions for all issues within the clinical operations study team.
Oversee the monitoring, implementation and corrective actions for study progress using available study management tools.
Identify and develop risk management and contingency plans.
Review and provide input into the creation and coordination of clinical study documents.
Provide appropriate training for team members to ensure consistent execution of all study related activities.
Drive the cross-functional team members to ensure timely creation of protocols and study deliverables.
Participate in CRO/vendor selection process for outsourced activities as applicable.
Manage Clinical Research Organization (CRO) interactions, including sponsor oversight of relevant functional activities (e.g., study management, monitoring, site management, project master files, and data management) as applicable.
Collaborate with the Legal Department to develop study contract templates across the trial and specifically for each study site.
Monitor all study progress. Ensure compliance with relevant regulations, guidelines, protocols and work instructions by maintaining regular interaction with assigned CRAs and study sites. Review monitoring reports and periodic review of data quality. Identify potential study issues and recommend/implement solutions.
Work with Clinical Data Management to ensure database availability, CRF design, collection of CRFs and queries (CRF and Query Locks), and other database lock activities according to previously approved timelines
Responsible for the overall quality of all clinical operations activities for all assigned studies.
Share and promote the best practices within the teams to enhance performance
Carries out duties in compliance with established business policies.
BS/BA degree in science or related field.
Minimum 5- 8 years’ experience as a Clinical Trial Manager or related area
Clinical trial management experience with demonstrated ability to manage and deliver results for a large portfolio of complex clinical studies.
Travel is expected to be 30%. Travel to sites for study initiation, training and assessment of research study team activities.
Strong computer skills including knowledge of Microsoft Excel and Word
Prior experience managing clinical trials for or within the biotech or device industry, including CRO management, clinical site monitoring, and knowledge of the basic data management processes
In-depth knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines.
Strong management skills with proven team building skills.
Data management and statistics
Strong computer skills using Microsoft Excel, Word, and Outlook.
Ability to work within established timelines, in a fast-paced environment.
Organizational and priority management skills
Good interpersonal skills and ability to interact with people at all levels and within all departments of the company
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities. To request an accommodation, please send an email to email@example.com
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org