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Associate Director, Clinical Operations

Anthera Pharmaceuticals, Inc.

Location:
Hayward, CA
Posted Date:
7/9/2014
Position Type:
Full time
Job Code:
Assoc. Director, Clinical Ops
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Clinical Operations, Clinical Trial, Clinical Trial Manager,

Job Description

Job Title: Associate Director, Clinical Operations

Reports To: Senior Director, Clinical Operations

Department: Clinical Operations

Job Location: Hayward, California

Position Type: Full-time, Exempt

Position Summary:
•   Responsible for coordinating and monitoring the logistics of clinical trials

Essential Functions:
•   Coordinate and track completion of study start-up, conduct, and closeout activities to industry and corporate standards
•   Ensure the progress and completion of projects according to timelines
•   Prepare and present regional project specific updates
•   Lead or assist in the writing of clinical documents such as protocols, study reports, study manuals, and annual reports
•   Monitor safety surveillance and reporting activities
•   Oversee data management processes including collection and cleaning of clinical database, reconciliation of clinical and safety databases, and data interpretation and evaluation
•   Assist in the construction of Clinical Operations processes including development and writing of SOPs, creation and organization of study Trial Master Files, and clarification of organization and workflow structures
•   Site management activities including: review monitoring reports, interact with study monitors, track site errors or other indicators of site difficulties, identification of potential problem sites and development of corrective action plans as required, acting as contact, as needed, for clinical sites
•   Experience with integrated systems (ECRF, TMS, IWRS)
•   Other duties as assigned

Requirements

Education:
•   BA/BS degree in biological science or nursing required

Experience:
•   7+ years of clinical research in the biotechnology/pharmaceutical industry
•   Multi-center clinical trial management experience, specifically experience in Phase 2 and Phase 3 US and international clinical trials
•   Experience managing CROs, central laboratories, and other clinical study vendors
•   Experience preparing clinical trial budgets and contracts
•   Knowledge of ICH-GCPs and 21 CFR is required
•   Experience with IVRS and/or EDC is desirable

Computer Skills:
•   Proficiency with MS Word, Excel, and PowerPoint is required
•   Proficiency with MS Project is preferred

Extra Skills:
•   Strong leadership and management skills
•   Excellent team work and collaboration skills
•   Outstanding written and verbal communication skills
•   Independent, innovative, and creative thinker
•   Knowledge of scientific principles and concepts
•   High level organization and time management skills
•   Must be able to work in a fast paced start-up environment with demonstrated ability to juggle multiple competing tasks and demands

Preferred Certifications/Licensures:
•   None

Travel Requirements:
•   Low, < 15%  (domestic and international)

Direct Reports:
•   None

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