Clinical Project Manager III (Non-MD) in South San Francisco, CA at Apex Life Sciences

Date Posted: 11/2/2018

Job Snapshot

Job Description


Primary Job Function 

Provide program-level leadership and promote operational excellence ensuring successful execution of Data and Statistical Science (DSS) deliverables. 

Position Accountability/ Scope 
• Accountable for execution and on-time delivery of planned DSS milestones for clinical technologies from start-up through close-out 
• Drive DSS study team operations and connect with cross-functional study teams to deliver trials and programs. 
• Develop and sustain strong relationships between internal stakeholders, external vendors, cross-functional peers, and DSS senior management 
• Synchronize deliverables between DSS, offshore resources, and vendors to deliver outcomes as planned 
• Influential in setting the strategy for Data Sciences (DS) 
• Management of operations through metrics. Categories include, but are not limited to, data, systems, general operations, and milestones 
• Reports into the Director Clinical Data Sciences and has accountability for global study planning and execution. 
Core Job Responsibilities 
• Responsible for program/compound-level timelines, while ensuring compliance and quality. 
• Responsible for the oversight of risk mitigation/risk management and contingency plans at a program level for all DSS deliverables 
• Influence and participate in clinical strategy team; including but not limited to protocol development and clinical technologies 
• Set expectations with the DSS team, the clinical study team, DS vendors, TA, and other external teams regarding timelines, processes and general coordination of the program 
• Communicate with confidence and leadership with these groups for prioritizations, actions, and resolutions throughout the life of a program 
• Act as a point of escalation for internal and external issues 
• Lead clinical study team in the development of key clinical trial systems, study conduct and study close-out as related to DSS operational activities 
• Oversee all Data Sciences timelines and metrics for assigned clinical trials 
• Lead DSS-related cross-functional meetings with clinical teams, safety teams and physicians 
• Oversee all vendor contracts for assigned clinical trials including accountability for Statement of Work (SoW) and Change in Scope 
• Participate in DSS-related cross-functional meetings with stakeholders as appropriate 
• Ensure stakeholder confidence in the health of the study by leading meetings to effectively communicate expectations, progress, issues and resolution 
• Partner with Total Quality Management Lead to ensure highest quality of team deliverables 
• Participate in any FDA or other regulatory meetings regarding assigned clinical trials 
• Influence decisions and approaches through effective negotiation 
• Ensure quality assurance as a measure to achieve audit and database lock readiness for assigned clinical trials and programs 
• Accountable for any audit findings regarding process execution or data integrity for any assigned clinical trial. 
• Mentor team members. 
• Accountable for supporting and utilizing Data Sciences policies and procedures 
Qualifications 
• Bachelor’s (Master’s preferred) degree in business, management information systems, computer science, life sciences or equivalent. 
• 5 to 8 years of direct clinical development experience. 2+ years of clinical development management. Phase II and III experience. 
• Demonstrated strong leadership competencies with broad business orientation and experience in leading teams in the management and completion of clinical trials. 
• Proven track record of successful studies (delivered on time, within budget, and with high quality). 
• Recognized leader in process development (SOPs, Global Regulations, OEC, Outsourcing) and the application of procedures to the business. Recognized as a leader and key contributor to initiatives and advancement of DSS as an organization. 
• Knowledgeable in the end-to-end clinical systems development cycle. 
• Demonstrated effective communication skills. 
• Ability to develop advanced knowledge of major concepts of key systems. 
• Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance. Creates a learning environment, opens to suggestions and experimentation for improvement. Embraces the ideas of others, nurtures innovation and manages innovation to reality. 
• Learns fast, grasps the 'essence' and can change the course quickly where indicated. Raises the bar and is never satisfied with the status quo




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