Senior Clinical Scientist
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Senior clinical Scientist for our client in Lawrenceville, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you are up to the challenge, then take a chance at this rewarding opportunity!
Position: Clinical Scientist
Location: Lawrenceville NJ 08648
Anticipated Schedule: 40hours/week
Primary Responsibilities: Job Description – 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 BMS 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.
Interested in applying?
Contact Joy Retanan at (646) 695-2949 or at http://www.linkedin.com/pub/joy-retanan/85/4ba/333 or send your resume to Joy.Retanan@eclaro.com now.
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.