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Clinical Study Manager (Contractor)

Employer
Santen, Inc.
Location
Emeryville, CA, United States
Start date
Dec 27, 2018

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Discipline
Clinical, Clinical Research
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay
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Job Details

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.


SKILL REQUIREMENTS:
  • 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.
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Company

Santen is a global pharmaceutical and medical device company focused solely on ophthalmology. We’re committed to serving serious unmet needs by developing innovative solutions that protect vision and, in turn, preserve quality of life for people around the world.

Santen USA, located in Emeryville, CA, is an important part of our ophthalmic research, development, and commercialization efforts worldwide and the home of our regional business teams. By leveraging our deep industry knowledge and a network of external partners, we aim to deliver game-changing therapies and make hope a reality for people facing vision impairment and loss.

Our deep roots start in Japan, Santen’s worldwide headquarters, where the company began in 1890. Since then, Santen has become an established leader in the Asian and European prescription ophthalmology marketplaces and continues to expand across global markets, including the United States. Today, Santen employs more than 4,000 people worldwide and sells specialty ophthalmic products in more than 60 countries.

With a clear focus on vision, we aim to deliver the highest quality products, to act with integrity, to earn the trust of our partners and customers, and to deliver sight-saving innovations to physicians and patients who are waiting for them.
 

 

Company info
Website
Location
6401 Hollis Street
Emeryville, CA 94608
 United States
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