Clinical Operations Consultant (COTL)
Clinical Development (CLN)/Clinical Technical Operations (CTO)
Sr.Director of Clinical Development
Working with closely with the Sr. Director Clinical Operations and the Development Team Leader(s), the Senior Director, Clinical Operations directs global clinical operational activities for, guiding activities and influencing colleagues in a highly matrixed environment. The incumbent will manage activities related to executing clinical studies in support of development programs in accordance with company SOPs, FDA, & ICH guidelines and regulations.
The Clinical Operations Consultant (COTL) will lead the operational strategy for trial execution, implementation, monitoring, analysis, data delivery and regulatory submission. He/she will lead the successful execution and timelines for clinical trials drawing on a high level of expertise with clinical and regulatory requirements, both local and international, for clinical operational processes and requirements.
§ Lead overall operations program/team responsible for execution of global clinical trials; oversee individuals managing operational execution of global clinical protocols for MTDA.
§ Provide clinical trial oversight and management, vendor and CRO performance (including bid/contract, budget/adjudication) and regulatory quality delivery of clinical trials according to corporate processes and timelines.
§ Work collaboratively with internal and external staff associated with clinical operations as well as CROs and vendors associated with operational functions.
§ Recommend and/or assess potential CROs and vendors in collaboration with Sourcing and other colleagues.
§ Lead data review and discrepancy resolution, team meetings/presentations for a clinical trial with senior management, in the US, EU and Japan, as needed.
§ Define and present complex operational objectives as required for senior management.
§ Oversee data collection activities for clinical programs: CRF, SAE assessment, queries, and follow-up, annual reports, investigator brochures, NDA etc.
§ Reports to Sr. Dir Clinical Dev (CTO)
§ Guides and mentors colleagues and indirect reports in a complex matrixed environment while overseeing a global clinical trials.
§ Works cross-functionally and collaboratively with Project Management, Medical, Regulatory, Commercial, R&D and other key business areas in the U.S. and globally.
§ BS or higher level degree.
§ Strong ability to build peer relationships and communicate effectively with company disciplines, cross-functional, and external teams.
§ 10+ years of increasing responsibility in clinical operations in a pharmaceutical company or CRO with a strong background in clinical trial design.
§ Successful experience in a large pharmaceutical company and complex matrix-based organization.
§ Proven history of drug R&D successes as evidenced in publications and regulatory success milestones (EOP2, NDA).
Knowledge and Skills:
§ Expertise in clinical and regulatory requirements, both local and international, of the clinical medicine and drug development processes.
§ Expertise in outsourcing and CRO management; outstanding budget oversight and adjudication skills.
§ Highly analytical, scientific mind with exceptional problem-solving skills.
§ Confident operations leader with proven ability to apply knowledge base to effectively manage, mentor and motivate staff in a matrix environment to achieve corporate objectives.
§ Superior interpersonal skills coupled with multicultural awareness. Able to successfully establish relationships, communicate effectively within/across company disciplines and thrive within a global, highly matrixed organization.
§ Skilled at leading external teams at remote locations.
§ Well-honed project management skills; proven ability to simultaneously manage activities associated with multiple clinical trials with short timelines in a fast-paced setting.
§ Attention to detail and commitment to high quality and on-time deliverables.
§ Outstanding computer skills including MS Office.
§ Willingness to travel domestically and internationally.
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