Clinical Scientist II: Respiratory
Participate in all aspects of clinical development and study management under the direction of the Director, or designee, which includes providing scientific, and/or logistical support to planned and ongoing international trials
Duties and 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 international 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. CRO management.
* 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.
* Qualified candidates will have a bachelor's or advanced degree in life sciences and at least 5 years experience in clinical research.
* CRO management experience
* Clinical trial management and protocol development experience required.
* Medical and/or scientific knowledge in multiple therapeutic areas advantageous. Individuals with Respiratory clinical trial experience are preferred.
* 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).