Clinical Study Manager - Medical Device

Location
Emeryville, CA, United States
Posted
Apr 12, 2019
Ref
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Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
PRIMARY PURPOSE OF POSITION:

Play an essential role in the development and implementation of global clinical research projects by managing the clinical operation 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.
  • 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:
  • Eight or more (8+) 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.