Clinical Study Manager (Contractor)
DESCRIPTION OF DUTIES:
- The Clinical Study Manager will primarily support the DE-117 U.S. Glaucoma program with efficient planning and execution of a Phase 3 Clinical study
- Deliverables: Initial focus will be on study start-up including identification of clinical sites, drafting of study protocol and ICF, and oversight of outsourced monitoring & communication plan, as well as source document worksheets, and providing ongoing critical program support to Clinical Lead for data validation and preparedness for database lock for all studies in the DE-117 program.
- Key milestones supported by this role will include: Selection of Study Sites by October/November 2018, finalization and approval of Protocol and ICF for the study by November 2018, readiness of study plans for approval and clinical site activations supporting 'First Subject In' by Jan-Feb 2019, and timely completion of enrollment and Database lock in first half of 2019.
- Five or more (5+) years of clinical research experience preferably in ophthalmology with a BS degree in a scientific discipline, RN, BSN degree or equivalent; MS, PharmD and/or PhD preferred.
- Prior experience in selection and management/oversight of CROs and other Vendors required
- Significant experience in the oversight of day-to-day clinical operational aspects of drug development.
- Must have the ability to make high level decisions and work effectively within a team
- With minimal input from management, must be able to set and prioritize goals and objectives; excellent time management and organizational skills.
- Demonstrated track record of driving projects/deliverables to completion within established deadlines.
- Proven ability to manage teams.
- Strong verbal communication and scientific writing skills, and good interpersonal/group skills.
- Must be able to communicate information between team members and with senior level management both inside and outside of Santen.
- Must demonstrate tact and the ability to positively influence others across all organizational levels.
- Must exercise good judgment regarding routine and non-routine assignments.
- Significant knowledge of FDA and ICH regulatory requirements e.g. Guidances, guidelines, CFR, etc. and implementation guidelines.
- Understanding of scientific and statistical principals vis a vis clinical trial design and analysis/presentation/reporting of data collected in clinical trials.
- High degree of computer proficiency, preferably in MS Office environment.
- Highly detail oriented.
- Adaptable to changing regulatory environments.
- Flexible team player with the ability to work in a changing environment.
- Ability to work collaboratively and effectively with people from different cultures (e.g., Europeans, Japanese); previous work experience with Japanese companies a plus.