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Sr. Clinical Study Manager - Medical Device

Employer
Santen, Inc.
Location
Emeryville, CA, United States
Start date
Apr 12, 2019

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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

PRIMARY PURPOSE OF POSITION:

Play an essential role in the development and implementation of global clinical research projects by managing the clinical operatin activities of assigned studies. The role functions as part of Santen's medical device clinical research group on behalf of the InnFocus business unit which produces minimally invasive devices to treat glaucoma patients.

MAJOR DUTIES OF POSITION:
  • Responsible for development and implementation of study protocol(s) and other study documents (Investigator's Brochure, Case Report Forms, Informed consent Documents, etc.) in accordance with Good Clinical Practices (GCPs) and current Standard Operating Procedures (SOP(s)).
  • Ensure that clinical trials are conducted in compliance with all relevant regulatory requirements.
  • Function as the overall lead on one or more clinical study projects
  • Manage clinical operation activities to meet enrollment targets according to the projected timeline.
  • Ensure that departmental SOPs meet operational and regulatory requirements.
  • Maintain clinical study files (including regulatory documents, CRFs and TMF) and organize audits of these files in preparation for internal and external audits.
  • Interface with CRA's and clinical sites regarding questions on clinical protocol requirements.
  • Participate in negotiations and preparation of legal and financial documents (e.g. contracts, budget proposals, confidentiality and indemnification agreements and insurance).
  • Assist with evaluation and selection of sites, vendors (e.g., reading centers), consultants, CROs, etc.
  • Work with Clinical Science, Biometrics, Device Safety and other departments to coordinate the review, evaluations, validation and reporting of moderate to complex clinical data.
  • Develop and maintain close working contacts with other functional areas such as Regulatory, R&D, Business Development and Strategic Marketing, Finance at Santen to facilitate clinical trials research.

KNOWLEDGE AND SKILL REQUIREMENTS:
  • Ten or more (10+) years of clinical research experience, preferably with some experience in ophthalmology.
  • BS degree in a scientific discipline, RN, BSN degree or equivalent; MS, PharmD and/or PhD preferred.
  • Knowledge of FDA, ISO and ICH clinical trial regulatory requirements.
  • Prior clinical study management experience across all stages of the study project, including planning/startup, execution, and closure, preferably in medical device.
  • Prior CRO/vendor management experience.
  • Ability to make high level decisions and work collaboratively and effectively within a team.
  • Strong verbal communication and scientific writing skills.
  • Working knowledge of scientific and statistical principles 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 environments.
  • Highly detail oriented.
  • Demonstrated track record of driving projects/deliverables to completion with established deadlines.
  • Excellent time management and organizational skills.
  • Ability to work collaboratively and effectively with people from different cultures (e.g. Europeans, Japanese); previous work experience with Japanese companies a plus.

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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