Clinical Scientist II

Position SummaryParticipate in all aspects of clinical development and study management under the direction of the Director, Associate Director or designee, which includes providing scientific, and/or logistical support to planned and ongoing trials Description of Duties & Responsibilities * Author drafts of study synopses, protocols, protocol amendments, Monitoring Plan and informed consents for Phase II-IV studies. * Contribute to the preparation of Investigator's Brochures and IND annual reports. * Prepare study report shells. Contribute to or review drafts of study reports. * Provide input on CRF design. * Review edit check specifications with Data Management. * Operationally manage one or more clinical studies. * Participate in the development and review Statistical Analysis Plans. * Field clinical site operational questions during conduct of the clinical trial. * With TA management and other functional area input, work with Project Management to establish and revise timelines for studies/projects. * Closely monitor and track clinical trial progress as appropriate. * Review lab, ECG results of patients in clinical studies looking for evidence of toxicity (or for evidence at baseline that patients with significant abnormalities are being enrolled inappropriately). * Interact with PR & D to ensure that there is adequate clinical supplies for a given clinical trial. * Review clinical supplies package diagram and labeling. * Assist in planning Investigator Meetings. * Evaluate CROs and vendors (patient recruiting services, labs, centralized ECG) for participation in programs. * Assist with preparations for advisory board and regulatory agency meetings. * May contribute to scientific/clinical evaluation of potential in-licensing candidates. * May interact with Marketing to support commercialization of products. * Attend internal and external meetings. * Contribute to the development of documents such as INDs, ISE, ISS. * Assist in preparing briefing books, abstracts, manuscripts, poster presentations of clinical study findings and results. Position RequirementsQualified candidates will have a bachelor's or advanced degree in life sciences and at least 5-8 years experience in clinical research. Clinical trial management and protocol development experience required. Strong written and verbal communication skills are required as well as proven ability to interact with different functional groups. Other key qualifications include knowledge of GCP/ICH guidelines and FDA regulations, experience with clinical trial design and basic knowledge of statistics, good organizational, interpersonal and presentation skills, proficiency in computer and software skills (Word, Excel, PowerPoint).