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PHC Global Study Associate Full-time

at Genentech in California (Published at 17-05-2018)

Considering local candidates only.


Position Summary


Personalized Healthcare (PHC) creates opportunities to improve outcomes for patients today and in the future. The Product Development Personalized Healthcare (PDP) function aims to drive Roche enterprise transformation across the Pharma value chain by

  • Accessing meaningful data at scale (high-dimensionality datasets with longitudinal clinical trial data, real-world data, whole genome sequencing, transcriptomics, immune system profiling, anatomic and pathology imaging data, and digital health data)
  • Applying advanced analytics to accelerate insight generation

  • Feeding forward insights re: disease activity/disease characterization to inform research and development decisions which improves our internal productivity and provides evidence to inform external decision-makers including patients, healthcare providers, governments, regulators and public and private payers.

As a PHC Global Study Associate, you will report to and work in close partnership with the Head of the Business Management Office and colleagues in PHC Data Science. You will partner with PD PHC Data Scientists to manage overall operation of the non-interventional/observational studies including project planning, timeline management, budget and resource tracking including work requiring ex-Roche collaborations with vendors/CROs/academic organizations. You have a customer orientation and are a proactive individual who takes full ownership of assignments. You collaborate willingly with many peers and external partners to drive for results. You are an adaptive individual that looks for data and observable trends to make the process and the function more effective and efficient.


Primary Accountabilities and Responsibilities

  • Study Lifecycle Management: Supports feasibility assessments with vendors/preferred providers/collaborations; Sets up study in appropriate study systems (e.g., Master Data Management System, Clinical Trial Management System, eTMF, etc.); Manages timelines for preparation and review of protocols/study analysis plans and appropriate scientific review and approval; Ensures knowledge management and compliant deliverable storage and safe-keeping in accordance with applicable GCP/GVP and regulatory guidelines.
  • Process Management: Works independently with strong organizational and proactive approach to work; Stays current with managing expense capture, updating relevant systems , shepherding contract initiation and contract completion transitions
  • Service Provider Management: Vendor transaction/documentation support
  • Resource Management: Manages FTEs/Project Variable Spend to approved budgets proposed to either LSPC or PHC Governance.
  • Communications/Change Management: Communicates effectively to drive team project advancement; Acts as knowledgeable go-to person for study guidance; Facilitates lessons learned to manage performance to original intended outcomes/objectives and feed learnings to future studies of a similar nature.
  • Project Coordination: Tracks study plan progress and actions and issue management associated with specifically assigned projects.
  • Innovation: Monitors study conduct and collects data across studies performed to develop business solutions and workarounds and contingency plans to optimize the process; Recommends and implements innovative process ideas to impact PDP study management.
  • Ensure data and insights sharing: Responsible for final work products and scientific publication findability and accessibility on functional portals/online channels and official repositories.

Skills/Abilities

  • Business Excellence: Contributes solutions that streamline efficient operation of the PDP function; Acts as go-to person for study operational guidance; Good at developing prioritization of own work queue to get things done; Knows how to organize people and activities
  • Collaboration: Applies curiosity and continuous learning to achieve deliverables efficiently and effectively; Skilled in establishing a collaborative and respectful team/group environment; Contributes to group learnings from success and failures.
  • Communication Produces well-organized and timely responses via e-mail.; Simplifies messages to achieve effectiveness in both written and oral communications; Proficient in creating non-technical presentations; Effective communication with business partners
  • Initiative Achieves impact for the PDP function; Shares their plans and follows through on commitments made; Able to define priorities and focus on areas that add value; Initiates deliverables without complete instructions/scope; Self-motivated and disciplined to deliver results. Asks for feedback to continuously improve own work and that of the group
  • Influencing Demonstrated skills in negotiating requests/deliverables to achieve desired end outcomes and balance work efficiently; Effectively influences PDP business partners and management
  • Problem-solver: Demonstrate ability to gather, verify and analyze data to support group’s data-driven decision-making; Reliably solves for significant administrative and logistical problems
  • Leadership: Learns about corporate strategy and PD agendas through project assignments; Understands Pharma and PD strategic objectives; Manages accountability for their work maximizing value for PDP; Speaks up and volunteers to lead new work scope to support team effectiveness

Qualifications

  • University/ college degree
  • 2+ years experience working in an drug development operations role preferred
  • 3+ years’ work experience being agile and adaptable in order to keep up in a fast-paced, dynamic work environment
  • Experience and expertise in problem-solving, operational excellence and stakeholder management
  • Proficiency in using with study management-related systems very helpful (e.g., MDMS, CTMS, eTMF, SAP, etc.)
  • Experience working with multi-cultural teams and/or global (multi-site) is highly preferred
  • Ability to learn systems/processes quickly
  • Ability to attune to people’s unspoken needs
  • Ability to find a pragmatic solution


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