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Manager, Clinical Operations

StemCells Inc.

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Location: Newark, CA Posted Date: 4/9/2013 Position Type: Full time Job Code: Clinical-BSP Required Education: Bachelors Degree Areas of Expertise Desired: Clinical Data Management
Clinical Research

Description

StemCells, Inc. is engaged in the research, development, and commercialization of cell-based therapeutics and tools for use in stem cell-based research and drug discovery. The Company’s lead therapeutic product candidate, HuCNS-SC® cells (purified human neural stem cells), is currently in development as a potential treatment for a broad range of central nervous system disorders.  Clinical trials are underway in Spinal Cord Injury and dry Age-related Macular Degeneration.  StemCells also markets a range of stem cell research products under the SC Proven® brand, and offers contract cell process development and production services.

We are currently seeking a Clinical Operations Manager who will assist in the management of the Company’s clinical trials.  This position reports to the Vice President, Clinical Operations.  

Responsibilities will include:

• Provide leadership within the assigned therapeutic area(s) for the successful management of StemCells' clinical trials, managing specific aspects of the trials and/or projects  
• Responsible for overseeing studies relating to assigned therapeutic area in conjunction with other Clinical Operations Personnel.  
• Defines study milestones and deliverables and executes to ensure timelines, budget and quality are met in conjunction with Project Management and Department Management
• Strategizes resources for projects within the therapeutic area
• Provides assistance with management and oversight of CRO
• May lead the planning and execution of successful Investigator Meetings
• Manages all tasks required to deliver the clinical study, including input to operations sections of protocol and CRF, trial start-up contract and budget agreements, site initiation, Data Monitoring Committee meetings, conduct and close out activities. Responsible for ensuring adequate clinical and non-clinical supplies.
• Responsible for overseeing adherence to corporate and compliance policies where applicable
• Participates in cross-functional teams and may lead clinical operation activities in facilitating communication and interaction amongst internal and external team members
• Ensures that the study team is up-to-date on current program status and priorities and ensures the goals/objectives are aligned with the corporate goals
• Provides regular status reports and metric updates of studies to senior management
• Works with other Clinical Operations personnel to identify risks within studies and proactively plans mitigation strategies
• In collaboration with other Clinical Operations personnel, solves problems and uses judgment and experience referring to national and international regulations, vendor relations and investigator interactions
• Assists with identifying outsourcing vendors for upcoming projects and assists in the RFP process to select a vendor and execute a contract
• May be responsible for negotiating scope of work and contracts with outsourcing vendors
• Ensures study training to all internal and external team members to assure consistency and compliance across study
• Participates in internal/external audits of vendors/sites
• Works closely with the Medical Monitor regarding safety reporting and interacts with data management function to ensure timely and accurate data for safety monitoring committees
• Responsible for organization of trial related clinical data and assembly for review by Medical Monitor
• Assists with the writing of clinical documents such as study reports and annual IND reports
• Assists in reviewing monitoring reports and correcting/tracking outstanding issues identified by the monitoring report
• Assist with the coordination of data review with cross-functional team to support database lock and Clinical Study Report
• Adheres to StemCells’ values and company policies and procedures

StemCells, Inc. offers a comprehensive and competitive compensation package, as well as generous paid time off in addition to Company observed holidays, and Medical, Dental and Life Insurance. We promote a culture in which employees are respected and rewarded for hard work, innovation, personal initiative, and teamwork.  

For more information about StemCells, Inc., please visit http://www.stemcellsinc.com

To apply, please send your resume/CV to staffing@stemcellsinc.com, Subject: Clinical- BSP or FAX your resume/CV to: Staffing at (510) 456-4001.  No phone calls please.

Direct applicant only; no agencies, please.  EOE

Requirements

Candidate must possess:

• Must have a Bachelor’s or equivalent and 8-10 years in the pharmaceutical industry with at least 3 years leading clinical trials and managing direct reports
• Demonstrated leadership and managerial responsibility  
• Has a broad knowledge of medical terminology, drug development processes, industry standards, GCPs, clinical trials monitoring, regulatory compliance and an understanding of statistical reporting
• Flexible with ability to adapt to changing priorities and interact with site investigators
• Strong communication skills (interpersonal, written, verbal, listening)
• Effective time management (timelines, schedules, task prioritization)
• Strong facilitation and negotiation skills
• Ability to problem-solve, build teams and lead and motivate others
• Effectively interact with customers, partners and co-workers internal/external to the department and/or company in accomplishment of business goals and objectives
• Uses professional and technical concepts in addition to company policies and procedures to solve a wide range of problems
• Exercises judgment within generally defined company practices and policies to determine appropriate action and solutions
• Strives for the achievement of excellence
• Displays a high level of commitment and professionalism
• Must be willing to travel up to 25% (domestic and international)
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