Manager, Study Team Support

South San Francisco
California, United States of America


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The Position

Relocation is not designated for this position. 

GENERAL POSITION SUMMARY/PURPOSE:
Study Team Support (STS) is part of the broader PDG organization and supports the execution of clinical studies. STS serves as the primary point of contact and business partner for PDG Study Management Teams (SMTs) for all clinical systems and services that SPE (Systems and Process excellence) offer through innovative evaluation, deployment and management of clinical, and non-clinical systems and processes by providing centralized, cross-system, process and systems support. Managers directly support STS vision and mission by providing coordination, high quality management, coaching and functional expertise to staff and other partners and stakeholders to ensure the appropriate study-specific systems set-up, User Acceptance Testing (UAT) and ongoing maintenance for PD (and Pharma Research & Early Development (RED)) clinical studies. As such, Managers in Study Team Support oversee and manage staff who are accountable for leading, directing and efficiently delivering clinical systems and innovative solutions in support of clinical trials. STS works cross-functionally across PDG, with PD, RED, Information Technology (IT) and other Roche partners, as well as external vendor partners supporting the work of SPE, PDG or PD overall. Managers are also part of the STS functional leadership team and they and/or their staff members may also be standing or ad hoc members of various internal/cross-functional work teams. Managers in STS may also have additional responsibilities to perform the role of site lead for the assigned functional areas.

JOB DESCRIPTION – PRIMARY DUTIES AND RESPONSIBILITIES:

1. Cross-Functional Team Membership & Leadership

  • Member of the local/global Study Team Support Management Team
  • Supports the STS leadership vision, contributes to STS strategy, and facilitates it’s execution
  • Leads STS Operational excellence at the site level through effective and efficient knowledge sharing
  • Participate in STS and SPE Operations level initiatives
  • May participate in broader, cross-functional STS and/or global initiatives
  • Represents STS in cross-functional PD/RED study teams and/or other cross-functional work teams. Self and team may act as standing or ad hoc members in short-, medium- or long-term study and/or other work teams. As needed and appropriate, addresses study systems, processes, tools and/or other study systems specific questions; provides updates; delivers presentations; etc.

2. Staff Management & Development
 

  • Cascades strategic and other relevant goals and objectives as well as budget and other resources to direct reports
  • Ensures that staff members are appropriately trained, developed and coached to comply with Roche and regulatory standards
  • Leads recruitment, hiring and onboarding activities
  • Manages assigned staff in order to maximize their capability and contribution in providing high-quality Systems Implementation and Study Support deliverables. Oversees staff members’ work to ensure consistently on-time, on-target and within-budget results
  • Conducts ongoing performance management and completes the required steps of Roche’s performance management process and cycle. Includes individual development plans/career discussions and actively contributes to performance calibration, talent management and succession planning processes 
  • Leads routine and ad hoc meetings with direct reports to ensure direct reports remain, at all times, fully abreast and apprised of evolving business needs and requirements as these relate to study systems, processes, related tools, or other relevant matters
  • Accountable for appropriate resourcing decisions and staff assignment
  • Ensures appropriate infrastructure for Study Team Support – clear roles and responsibilities, learning and development, technology, other tools, vendor partners and operating budgets
  • Undertakes special projects, as assigned, that further the overall success and effectiveness of Study Team Support, SPE and/or PDG overall
  • Where applicable, self and team may participate in the negotiation with and commissioning of external vendor partners to support the work of Study Team Support and/or the broader SPE, PDG or PD organizations
  • Creates a positive work environment by encouraging mutual respect, innovation and accountability at all levels (site, functional, global, projects/programs)
  • May tracks departmental expense budgets to ensure compliance with agreed parameters
  • Consistently complies with all governing laws, regulations, Roche Standard Operating Procedures (SOPs), company HR policies & procedures and other guidelines and ensures the same across his/her staff

3. Study Team Support Planning & Development

  • Supports the STS leadership vision, contributes to STS strategy, and facilitates it’s execution
  • Stays abreast of internal and external developments, trends and other dynamics relevant to the work of STS, PD and REDs to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for assigned study systems and/or other recurring and ad hoc responsibilities. Includes evaluating new system technologies and related tools to ensure PD/REDs has best-in-class study systems, processes and related tools. Ensures the same across direct reports
  • Self and team provide expertise in clinical study systems, systems testing, processes and related tools
  • Ensures direct reports work collaboratively and effectively with SMTs and other SPE Operations sub-functions to gather, analyze, and synthesize study specifications, goals and objectives and translate these into study systems, UAT, process and related tool requirements (includes required resources, such as any required budget, IT or external vendor partner support, milestones and key deliverables.) Drives best practices and ongoing continuous systems and operational excellence
  • Ensures direct reports aid SMTs in setting priorities, appropriate expectations, scope, functionality, timelines, etc. in each study plan
  • Self and team work with other STS functions to proactively evaluate potential synergies and interface requirements with existing systems and/or existing systems functionalities to understand potential points of leverage and/or alignment requirements for smooth systems interface and optimal user experience
  • Oversees and/or otherwise works with direct reports to proactively evaluate and plan for testing, deployment, training, other change management and maintenance requirements associated with new or otherwise updated study systems, processes and related tools
  • As needed, ensures direct reports support other SPE functions in preparing and/or delivering study systems assessments, recommendations and plans to PDG/PD leadership or other leadership teams to obtain approvals and secure the required resources
  • As needed, self and team provide input into Systems Management and/or Systems Support Services project or other work plans, service level agreements, standards, policies, procedures and protocols as these pertain to STS’s support of clinical studies
  • Supports his/her manager in developing annual and/or longer-range operational plans, objectives, budgets and other resource requirements for Systems Implementation
  • Expected to contribute to the development of global Systems Implementation and/or broader STS standards, processes and functional initiatives

4. Study Team Support - Operations/Administration

  • Maintains oversight of execution of work and deliverables across direct reports and any relevant external vendor partners. Includes playing a lead role in ensuring, where applicable, external vendor partners comply with contractual agreements
  • Oversees and guides development and maintenance of standard project timeline for study specific systems set-up and testing
  • Ensures direct reports effectively partner with SMTs and others in STS to assure set-up of systems based on current study needs and regulatory requirements. Includes managing and coaching others in activities related to systems set-up and testing
  • Ensures direct reports promptly resolve critical issues and provide timely and accurate responses to users and others relating to system best practices and regulatory compliance
  • Participates in regular functional forums pertaining to the work of Systems Implementation and/or the broader STS group (at all levels – site, global, etc.) to ensure consistencies, best practices and overall effective and efficient knowledge-sharing
  • Self and team support, as needed or otherwise appropriate, updates to SOPs and/or Departmental Operating Procedures (DOPs)
  • Oversees and/or otherwise completes routine and ad hoc analysis and reporting. Accountable to ensure staff members keep all internal customers, partners and stakeholders abreast of progress; including providing updates or other feedback regarding systems performance. Ensures analysis and reporting is done following prescribed departmental procedures, practices and protocols and using standardized reporting and communications tools/templates and other resources
  • Completes, leads, and/or assigns other special projects, as and when appropriate, or otherwise requested
  • Self and team are expected to routinely monitor study systems performance to ensure ongoing effectiveness, efficiencies, scalability, sustainability and regulatory compliance; including identifying and communicating issues or opportunities

QUALIFICATIONS & EXPERIENCE:

  • 5+ years of experience in areas relevant to clinical trials
  • Bachelors Degree required
  • Advanced Degree in related field is preferred
  • Project management certifications, e.g., PMP, PgMP, PMI-ACP, PMI-RMP, PMI-SP, is a plus
  • Advanced previous experience in development, deployment and/or maintenance of information systems in the pharmaceutical, biotechnology or related industry; to include user acceptance testing for computer systems
  • Advanced experience in supporting information systems
  • Advanced knowledge and past experience working with clinical trials management and/or clinical data management processes
  • Must demonstrate knowledge of, and/or training in, regulatory and system compliance
  • Broad understanding of international regulations, processes and issues in drug development. Includes in-depth understanding of GxP (Good Practices for quality guidelines and practices in the pharmaceutical/biotechnology or related industry), GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), and related systems that support clinical trials and clinical operations processes
  • Advanced project management and process improvement skills. In-depth knowledge of and past experience working with best practice project management and operational excellence methodologies and tools, such as value stream mapping, business process redesign, Six Sigma, LEAN, modeling and simulation, cycle time reduction, etc.
  • Previous people management experience is a plus
  • Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel)
  • Fluency in English and other language skills as needed

ABILITIES:

  • Demonstrates, or has proven abilities to demonstrate, Roche Values & Leadership Competencies
  • Proven abilities to function and operate effectively within a matrix environment 
  • Outstanding attention-to-detail
  • Regarded as a subject matter expert in clinical study systems, testing, relevant regulations, processes and related tools
  • Strong business acumen; has in-depth knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g., clinical development, regulatory, etc. and can proactively integrate multiple perspectives into study systems design, development, testing and deployment
  • Excellent time management & organizational skills: can prioritize multiple tasks and goals and ensure the timely, on-target and within-budget accomplishment of such
  • Strong interpersonal, communication and influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally
  • Strong business presentation skills: highly effective at summarizing and presenting the key considerations and decision-points
  • Confident and competent when interacting with varying levels of internal/external management: stays focused and on-point, and is able to raise problems or challenges in a productive and mature manner
  • Strong negotiation skills: can effectively drive discussions and decisions toward desired end results
  • Proven track record of effective decision-making: makes good business decisions and exercises sound judgment consistently and effectively balances decisions with imperatives for ethics and efficacy
  • Proven teamwork skills: has a proven track record of working highly effectively, efficiently and collaboratively with others. Has proven experience and skills working with multidisciplinary teams
  • Strong financial acumen: proven abilities for effective planning, development and oversight of project budgets and other resources
  • Aptitude or proven ability to manage others (can lead and motivate direct reports, as well as prioritize and oversee their work through to successful outcomes)
  • Ability to travel (<10%)

Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.

At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.


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