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Associate Director/Director, Clinical Operations

Ultragenyx Pharmaceutical Inc.

Location:
Novato, CA
Posted Date:
4/2/2014
Position Type:
Full time
Job Code:
CPM-20130621
Salary:
Required Education:
High school or equivalent
Areas of Expertise Desired:
Clinical Research,

Job Description

The Sr. Clinical Program Manager/Associate Director is responsible for the day to day management of a clinical trial and will manage the study management team, vendors, clinical monitors and clinical trial sites.  This position will also work closely with a cross-functional team to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets. This position is responsible for ensuring achievement of own or others’ project goals and objectives.  This person may have line management responsibilities. This person is able and willing to perform all duties or functions of subordinates. The core duties and responsibilities are delineated below.

Responsibilities:  
•   Oversee multiple programs and a key contributor to strategic direction of the dept.  Manages the operational aspects of clinical trials
•   Manages the study project plan, including timeline, budget,  and resources
•   Participates in study strategy development, protocol, CRF development, Clinical Study Report preparation, NDA submission, as appropriate
•   Prepares metrics and updates for management, as assigned
•   Proactively identifies potential study issues/risks and recommends/implements solutions
•   Participates in and facilitates CRO/vendor selection process for outsourced activities
•   Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project master files)
•   Works with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met
•   Prepares and/or reviews/approves study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines)
•   Manages clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
•   Participates in the development, review and implementation of departmental SOPs and processes
•   Recommends and implements innovative process ideas to impact clinical trials management
•   Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings
•   Serves as a liaison and resource for investigational sites
•   Reviews site study documents (informed consent template and study tools/worksheets), investigator contracts, and site payments
•   Participates in the selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function

Requirements

•   A Bachelor degree in a science or health related field required
•   10+ years of related clinical trial management experience
•   Experience in managing CROS, specialty labs and outside vendors
•   Experience with international trials
•   Experience with rare disease desired
•   Familiar with advanced concepts of clinical research and able to work effectively in a team/matrix environment
•   Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, is required
•   Must be willing to travel 20-30% of time
•   Ability to deal with time demands, incomplete information or unexpected events
•   Ability to provide clinical expertise to a clinical development in a specified product area or project
•   Must possess excellent interpersonal skills
•   Must have the ability to build and maintain positive relationships with management, peers, and direct reports
•   Excellent written and verbal skills required.  Must display strong analytical and problem solving skills.  Attention to detail required.

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