Senior Clinical Scientist
Management of the operational components of clinical trials for Phase I-IIa studies in support of global regulatory filings including IND, NDA, MAA, and life-cycle management programs.
Co-author complex protocols with minimal direction.
Interpret relevance of review comments and incorporate as appropriate.
Ensure protocol specific content and required sections are included in the Informed Consent Form.
Interact with and manage stakeholder expectations, with functional groups outside of Exploratory Clinical and Translational Research, to facilitate the successful development and implementation of assigned studies.
Operationalize multiple protocols within and/or across program(s), therapeutic area(s), and/or site(s) using project management tools.
Proactively identify potential risks that could impact project performance and/ or outcome and develop contingency plans and necessary actions to prevent or address problems regarding timelines, budget, resources, and quality.
Co-author and/or provide input into key study documents such as protocols and clinical study reports and participate in the development of rationale, objectives and protocol design to ensure consistency within program(s).
Drive and provide leadership for the development of study related documents with the input from team members: [e.g. operational components of the protocol (site monitoring plan, risk management plan, CRF instructions, study tools, informed consent, etc)].
Successfully drive 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.
Review and provide input on CRF development and data review and analysis plan to ensure that all protocol required data points are captured.
Lead process improvement teams and initiatives.
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 ability 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.
Synectics is an Equal Opportunity Employer
Website : http://www.synectics.com/
Synectics is one of the nation's foremost staff augmentation firms, working with a client base that includes some of the leading institutions and Fortune 100 corporations in the United States. We seek to bring the most highly qualified professionals to assignments that they will find challenging and fulfilling. We also seek to justify our clients’ expectations that every Synectics consultant will bring the highest possible effort to their endeavors every day. Our success has depended on our consistent ability to achieve both of these goals. Synectics serves an extremely diverse client base which represents an equally diverse range of industries and institutions. The technologies we support have always been responsive to this extremely broad spectrum. In order to fully engage with this continually changing commercial and technological landscape, our employees must draw on their own varying interests, skills and backgrounds. This insight, reflected in our daily practices, has always been our fundamental strength as a company, and it continues to serve us well in all our efforts.