South San Francisco, California
Who We Are
At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.The Position
PURPOSE: Provides the operational expertise and leadership to one or more clinicaloperations teams to ensure the effective and efficient delivery of alloperational aspects of one or more studies through all phases of ClinicalStudy Management (Plan, Initiate, Conduct, Close), in accordance with theappropriate quality standards including ICH/GCP and applicableregulations.MainResponsibilities and Accountabilities:
•Provides direction and leadership to one or more clinical operations teams
•Develops operational plans including site monitoring strategies, riskmitigation strategies, trial budgets, site selection, and clinicalsupplies management.
• Buildseffective and efficient high performing operations teams and ensures teammembers are aware of their accountabilities, responsibilities anddeliverables.
• Createsteam culture and promotes team spirit.
•Develops and maintains effective working relationships with SMT members, withparticular focus on affiliate teams, external CRO (for outsourced teams)and co-development partner study teams.
• Incollaboration with functional management, coaches, mentors, supports andprovides study specific direction to Study Management team members.
•Oversees the development and maintenance of study specific manuals created bythe GSA.
•Contributes to the development and management of the study timelines,resources, budget, risk and quality plans
• Ensuresoperational tracking tools are identified, including systems to meet the needsof the operations team and ensures reporting to the GSL.
•Develops and manages clinical study budgets (including HQ budget) andcontributes to the staffing/resourcing plans. Communicates variances inthe budget and action plan for resolution to the GSL.
•Establishes study milestones and ensures accurate tracking and reporting ofstudy metrics.
•Provides operational input into the development of protocol feasibilityquestionnaires.
•Provides clinical operations expertise to ensure operational feasibility anddelivery
• Leadsthe development and finalization of site feasibility questionnaires.
• Leadsthe creation of the study level patient recruitment plan and retentionstrategies based on feasibility data and input from the affiliate teamsand consultation with the GSL and OPL.
•Provides operational input and insight into all study related documentation(including protocol and informed consent form) and processes.
•Analyzes the feasibility data across countries with input from the affiliatesand makes recommendations to the GSL for the strategic country and sitedistribution and patient numbers.
•Oversees forecasting of clinical/non-clinical supplies
• Designsdrug assumption and supply chain process in partnership with Pharma TechnicalDrug Supplies, affiliates and GSL.
•Oversees the forecasting and management of non-clinical supplies to ensuresites have supplies to run clinical study.
•Delivers the operational elements of the study plan
• Chairsoperations team meeting and organizes the investigator meetings, monitortraining, CRO kick-off meetings.
• Ensuresthat reporting of SUSARs is established and maintained for the duration of thestudy.
•Proactively manages actual study level recruitment versus planned patientrecruitment status and communicates variance to the GSL and implementscontingencies in consultation with the GSL.
• Primarycontact with affiliates to maintain oversight of performance, issues, and theirresolution and identify systematic issues and coordinates any correctiveaction.
• Ensuresthe completion and finalization of any corrective and preventative action plansresulting from internal site audits.
•Oversees the maintenance of drugs supplies and resolution of issues with inputfrom the Pharma Technical Drugs Supplies.
Who You Are
Qualifications:Lifesciences degree or nursing equivalent and 5-7 years of experience in a clinicalresearch/a healthcare environment.
Skills& Knowledge:
Experience
• Provenclinical development experience of the operational aspects of all stages of Oncology clinical studies preferably working in aGlobal environment and/or including monitoring or leading affiliate teams,working with vendors and/or CROs, drugsupply management and planning operational activities to achieve database lock.
•Experience of project managing operational aspects of a clinical studyincluding development of timelines, budgets andresource plans.
• Goodknowledge of ICH GCP.
• Provenability to successfully achieve results within a multi-cultural andgeographically diverse team.
•Experience of working as a part of a large team and leading small study orfunctional teams, with a proven ability to be anactive member of the team and motivate and lead a small team to deliver againstcommitments.
• Welldeveloped written and verbal communication skills demonstrated by an ability topresent clear instruction/directionto teams at the same level in the organization and influence at higher levelsin the organization.
Competencies
• ProjectManagement
•Collaboration and Teamwork
•Negotiating
•Communication
•Personal Organization
Other:
•Attention to detail
•Proficient Computer skills
• Mobile:Some travel may be required
The next step is yours. To apply today, click on the "Apply online" button below.
Genentech is an Equal Opportunity Employer.
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