Management of the operational components of clinical trials for PhI-IIa studies in support of global regulatory filings including IND, NDA, MAA and life-cycle management programs.
CO-author complex protocols with minimal direction.
Able to interpret relevance of review comments and incorporate as appropriate.
Ensure protocol specific content and BMS required sections are included in the Informed Consent Form.
Interacts and manages stakeholder expectations with functional groups outside of Exploratory Clinical and Translational Research, to facilitate the successful development and implementation of assigned studies.
Operationalizes multiple protocols within and/or across program(s), therapeutic area, and/ or site(s) using project management tools.
Proactively identifies potential risks that could impact project performance and/ or outcome and develops contingency plans and necessary actions to prevent or address problems regarding timelines, budget, resources and quality.
Co-authors and/or provides input into key study documents such as protocols and clinical study reports and participates in the development of rationale, objectives and protocol design to ensure consistency within program(s).
Drives and provides leadership for the development of study related documents with the input from team members:
operational components of the protocol (site monitoring plan, risk management plan, CRF instructions, study tools, informed consent, etc) .
Successfully drives the operational components of study including site feasibility and selection, site initiation activities, site start up and patient recruitment, and preparation and/or review of appropriate clinical and regulatory documents.
Reviews and provides input on CRF development and data review and analysis plan to ensure that all protocol required data points are captured.
Leads process improvement teams and initiatives.
Qualifications Equivalent of Bachelor's degree (or RN) and 5+ years related experience, OR Master's degree and 4+ years related experience, OR PharmD/PhD degree with 3+ years clinically related experience.
Strong understanding of Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) Guidelines.
Knowledge of clinical research (Phase I-IV processes, procedures and timelines).
Experience conducting Phase I clinical trials required.
Strong project management experience and able to apply aspects at the protocol and program level.
Understanding of data management and statistical analysis process.
Thorough understanding of clinical pharmacology concepts and scientific principles.
Experience delivering projects with exemplary accuracy and attention to detail with the ability to work independently.
Bristol-Myers Squibb is an equal opportunity employer - M/F/Vet/DisabilityRequisition ID - 1501175

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