Sr. Manager, Clinical Operations - Emeryville, CA | Biospace
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Sr. Manager, Clinical Operations

Santen, Inc.

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Location:
Emeryville, CA
Posted Date:
9/13/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Clinical Operations,

Job Description


PRIMARY PURPOSE OF 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.

MAJOR DUTIES OF POSITION:

•   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.
•   Maintains up to date extensive knowledge and understanding of Good Clinical Practices, regulations and guidance documents and industry trends/best practices.
•   Writes clinical standard operating procedures and provides training to more junior level clinical operations colleagues.
•   Develops and maintains relationships with key opinion leaders (KOLs) and clinical scientists to support Santen development activities on a global basis.Suggests courses and seminars to attend to develop professional expertise in all facets of clinical operations.
•   Maintains up to date extensive knowledge and understanding of Good Clinical Practices, regulations and guidance documents and industry trends/best practices.
•   Interfaces with CRAs; a key contact with clinical sites regarding questions on the clinical protocol requirements, key contact with CRO.
•   Manages Global Clinical Operations activities working with Clinical Science, Biometrics, Device Safety and other departments to coordinate the review, evaluation, quality, validation and reporting of moderate to complex clinical data.
     o   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.)
     o   Develops the clinical sections for submissions to regulatory bodies (e.g. FDA, EMA, etc.) and IRBs/ECs (e.g. IDE’s, PMA’s Annual Reports, Pre-meeting Packages, Clinical Study Reports, etc.) for assigned project(s).
     o   Manages Clinical Operations activities to evaluate and select sites, vendors (e.g. IXRS, lab, reading centers), consultants, CROs, etc. for assigned studies.
     o   Develops monitoring requirements to assure quality monitoring activities.
     o   Enables negotiations and preparation all legal and financial documents (e.g. contracts, budget proposals, confidentiality and indemnification agreements, insurance).
     o   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 for assigned projects, including but not limited to, the following:
•   Execute smaller FDA submissions, like registration, export certificates, Technical File maintenance; interface with internal departments as resource regarding the study.
•   Maintain clinical study files, organize audits of these files in preparation for BIMO audits, maintain clinical trial documentation, IRB correspondence, FDA correspondence, potentially assist with preparation of scientific abstracts, slide presentations regarding study results,
•   Responsible for development and implementation of study protocol(s) in accordance with Good Clinical Practices (GCPs) and current Standard Operating Procedures (SOP(s)).
•   Manage clinical operation activities to meet enrollment targets according to the projected timeline, including being the key contact for external CRO’s.
•   Develops and maintains relationships with key opinion leaders (KOLs) and clinical scientists to support Santen development activities on a global basis.
•   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.

Requirements


KNOWLEDGE AND 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 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.

List working relationships inside/outside of the organization other than your Direct Manager:

•   Santen strategic planning groups such as the Core Team Representative, Clinical Scientist, Medical Monitor etc.
•   Other Functional Groups within Santen involved in the conduct of Clinical Trials such as Regulatory, Quality Assurance, Pharmacovigilance, Data Management etc.
•   Vendors involved in the conduct of Clinical Trails such as Clinical Research Organizations, laboratories etc.

PHYSICAL DEMANDS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must be able to:

•   Spend considerable time at the computer
•   Stand, kneel and stoop for filing
•   Use the telephone and communicate clearly with individuals who are both internal and external to Santen Inc.
•   Travel nationally and internationally, when required, up to 30%

WORK ENVIRONMENT AND ENVIRONMENTAL CONDITIONS:

The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

LEGAL REQUIREMENTS:

Authorization to work in the United States and travel with legally required documentation.