Clinical Study Manager - Contractor

Location
Emeryville, CA, United States
Posted
Nov 18, 2020
Ref
1040
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
COMPANY DESCRIPTION

At Santen, we’re innovating therapies to improve the quality of life for patients worldwide. Our single focus in ophthalmology enables us to challenge unmet needs in the field—through passionate research, successful collaboration, and clarity of commitment. With over 130 years of investigative insight, Santen remains committed to the discovery, exploration, and development of ophthalmic therapies. As a global company, Santen is expanding to accommodate new and evolving initiatives in ophthalmic research, regulatory management, production, marketing, or distribution. Our clinical development network spans three continents, with centers in Europe, Japan, and the United States.

We are in search of top talent to help us meet our aggressive and important goals.

ABOUT THE POSITION:

The Clinical Study Manager (6+ months contract position) will primarily support Global Clinical Operations management with efficient planning and execution of one or more assigned studies. Deliverables include study start-up, selection of clinical sites, drafting and finalization of study protocol and ICF, and vendor management for outsourced activities including creation of study plans, site monitoring and management including enrollment, follow-up, database lock and study closeout activities.

This position plays an essential role in the development and implementation of global clinical research projects by managing the global clinical operation activities of assigned studies. The role functions as part of Santen's global clinical research group. Responsibilities include the planning, execution, and interpretation of global clinical trials and data collection activities. Performs managerial functions of moderate to significant scope with a high level of independence.

ESSENTIAL DUTIES AND KEY DELIVERABLES:
  • Participates in strategic discussions regarding the design of global clinical programs and in reporting the progress of clinical programs by working collaboratively with the global Core Team and sub-teams.
  • Negotiates study timelines during project development and manage clinical operation activities to meet enrollment targets according to the projected timeline.
  • Utilizes budget software to develop study budgets and manages studies within approved budget guidelines.
  • Recommends and administers budgets, schedules and resource requirements for assigned projects.
  • Responsible for development and implementation of study protocol(s) in accordance with Good Clinical Practices (GCPs) and current Standard Operating Procedures (SOP(s)).
  • Manages global clinical operations activities for assigned projects, including but not limited to, the following:
    1. Prepares/procures of all manner of documents and supplies related to the clinical trial process (e.g. Investigator’s Brochure, Protocols, Case Report Forms, Informed Consent Documents, etc.)
    2. Develops the clinical sections for submissions to regulatory bodies (e.g. FDA, EMA, etc.) and IRBs/ECs (e.g. INDs, NDAs, Annual Reports, Pre-meeting Packages, Clinical Study Reports, etc.) for assigned project(s).
    3. Manages Clinical Operations activities to evaluate and select sites, vendors (e.g. IXRS, lab, reading centers), consultants, CROs, etc. for assigned studies.
    4. Develops monitoring requirements to assure quality monitoring activities.
    5. Negotiates and prepares all legal and financial documents (e.g. contracts, budget proposals, confidentiality and indemnification agreements, insurance, etc.).
    6. Monitors clinical studies to assure they are conducted in compliance with the protocol, Santen Standard Operating Procedures, Good Clinical Practice and appropriate regulatory requirements.
  • Manages Global Clinical Operations activities working with Clinical Science, Biometrics, Drug Safety and other departments to coordinate the review, evaluation, quality, validation and reporting of moderate to complex clinical data.
  • Represents Global Clinical Operations on project teams for assigned projects as requested.
  • Prepares and/or presents written and oral presentations regarding clinical trial progress/results.
  • Suggests courses and seminars to attend to develop professional expertise in all facets of clinical operations.
  • Writes clinical standard operating procedures and provides training to more junior level clinical operations colleagues.
  • Maintains up to date extensive knowledge and understanding of Good Clinical Practices, regulations and guidance documents and industry trends/best practices.
  • Develops and maintains close working contacts with other functional areas outside of GCD&MA e.g. Regulatory, Pharmaceutical Development, Business Development and Strategic Marketing, Finance, etc. at Santen to facilitate clinical trials research.

Develops and maintains relationships with key opinion leaders (KOLs) and clinical scientists to support Santen development activities on a global basis.

QUALIFICATIONS:

Core competencies, education, and experience.
  • Six or more (6+) 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 supervisory experience of operations personnel (e.g. CRAs, consultants, etc.) and vendor management preferred.
  • 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
  • Strong verbal communication and scientific writing skills, and good interpersonal/group skills.
  • Must be able to communicate information between regions 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.
  • Requires the ability to change the thinking of or gain acceptance of others in sensitive situations
  • Significant knowledge of FDA and ICH regulatory requirements e.g. Guidances, guidelines, CFR, etc. and implementation guidelines.
  • High level of 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.
  • Demonstrated track record of driving projects/deliverables to completion within established deadlines.
  • Must exercise good judgment regarding routine and non-routine assignments.
  • With minimal input from management, must be able to set and prioritize goals and objectives; excellent time management and organizational skills.
  • Proven ability to manage teams.
  • Ability to work collaboratively and effectively with people from different cultures (e.g., Europeans, Japanese); previous work experience with Japanese companies a plus.

For more information about our company and the work experience, please visit www.santenusa.com