Endo International Associate Director, Clinical Operations in Malvern, Pennsylvania
Associate Director, Clinical Operations, Research & Development, Malvern, PA
Endo International plc (NASDAQ: ENDP) is a highly focused generics and specialty branded pharmaceutical company delivering quality medicines to patients in need through excellence in development, manufacturing and commercialization. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA. Learn more at www.endo.com.
The Associate Director in Clinical Operations is a clinical trial leader at Endo, ensuring delivery of clinical study outputs that meet and exceed established quality, schedule and budget expectations. While the incumbent’s experience may have greater depth in a particular function, e.g. clinical operations or data management, their responsibilities for leading the operational execution of clinical studies crosses multiple domains.
May manage Clinical Operations personnel from Specialist through Senior Manager and contract staff.
Monitors, controls and reports performance of vendors against timeline, deliverables, budget and quality expectations.
Signs documents for activities as authorized and described by Endo policies, procedures and job descriptions.
ROLE AND RESPONSIBILITIES:
Ensure operational excellence and integrity through adherence with Endo policies and procedures, GCP, ICH, FDA and all other international regulatory requirements.
Manage cross-functional team to the achievement of clinical trial goals.
Establish and ensure adherance to study timelines in collaboration with study team; report progress and timeline deviations and manage stakeholders.
Proactively identify project risks and develop plans to mitigate them.
Assist with protocol design, consult on operational/logistic issues and ensure all operational aspects of the clinical trial are satisfactorily addressed.
Facilitate and assist in the preparation of patient study related materials and documentation.
Drive data quality management processes to identify critical data elements and ensure their efficient collection for central monitoring and statistical analysis.
Drive site selection and patient recruitment programs that deliver enrollment targets.
Establish a visible Endo profile with investigator sites during study start up and ensure site-to-sponsor communication is effective and efficient throughout the trial.
Ensure electronic clinical data streams are defined, understood by the study team, optimally sourced and efficiently implemented.
Contribute to statistical analysis plans, ensuring clinical trial objectives are aligned with the delivery of evaluable data.
Develop and ensure adherance to integrated site monitoring, data handling and review plans.
Ensure analysis-ready, clean databases are delivered that accurately reflect study conduct and support regulatory submissions/scientific publications.
Ensure completion of clinical activites to achieve database lock according to agreed timeline.
Train and supervise staff assigned to clinical trial projects.
Pro-actively manage and monitor Trial Master Files (TMF); ensure TMF components in custody of vendors are available and inspection ready.
Assist in preparation of Investigator Alert letters and SAE reports as required to ensure reporting timelines are met.
Assist with the preparation of regulatory documents including INDs, IND annual updates, briefing documents, CTAs, and regulatory meeting briefing documents as requested.
Contribute to the development of clinical study reports.
Monitor and report on key performance indicators.
Partner with outsourcing on vendor selection, operational, assessments, contract management and invoice approval.
Manage and coordinate with external service providers including clinical research organizations (CROs), EDC platform providers, laboratories and others, serving as primary point of contact, preparing scopes of work, ensuring agreed deliverables are achieved on time and monitoring key performance indicators.
Provide formal oversight and ensure inspection-ready documentation exists for sponsor obligations transferred to CROs and other providers.
Participate in due-diligence activities for in-licensing of new products.
Contribute to cross-functional projects.
Mentor and develop clinical trial team members.
Lead process improvement projects and other initiatives within clinical operations and data management.
BS degree required.
Minimum 8 years’ experience in clinical trial management.
Direct leadership experience in clinical trial activities outside of the US and/or in emerging markets preferred.
Minimum 3 years managing others as direct line manager and/or leader of matrix clinical trial teams.
Well versed in GCP and applicable FDA/EMEA/ROW regulations.
Broad and deep understanding of clinical trial management for the operational planning, execution and delivery of clinical studies domestically and globally.
Competency in the principles of clinical data management, data standards (e.g. CDISC) and the various tools and processes used to collect and manage clinical data from source (site) through lock.
Knowledgeable in the interaction between clinical operations and data management with a focus on the integration of the two disciplines.
Proficient in written and oral communication and experience in presenting to groups.
Ability to work with clinical trial and clinical data management systems, MS Office, electronic document management and other web-based systems.
Works autonomously under consultative direction toward long range goals.
Demonstrated ability to lead multi-disciplinary teams to the achievement of project goals.
Communicate proactively and appropriately and various levels within the organization and externally.
Anticipate problems and innovate effective plans for complex situations.
Partner with colleagues to build and maintain strong, collaborative relationships across functional areas within Endo, with Endo alliance partners and external service providers.
Negotiate effectively with colleagues to accomplish shared goals.
Ability to prioritize and manage multiple tasks; strength in organization and planning.
Consult and collaborate confidently with senior scientific and clinical research professionals.
Standard office environment and daily commute to assigned office location.
Business travel 30%.
Endo recognizes the advantages of a diverse workforce achieved through a commitment to equal employment opportunities.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled