Data Manager Oncology Head, US Medical Affairs

Hoffmann-La Roche Ltd California , MD 20619

Posted 2 months ago

The Position

Therapeutic Data Manager Head/Lead is accountable for the delivery of all of the data management deliverables from clinical trials (Local Affiliate and Multi-National Trials) sponsored by Genentech US Medical Affairs. The role includes oversight of the data management work conducted by external data management vendors, irrespective of whether business model used (for instance, full outsourcing or Functional Service Provider)

This role requires the data manager to be technically competent, have excellent customer service skills and a desire to engage customers in pursuit of new business opportunities. Additionally, this individual will have proficient organizational skills and the ability to assess future resource requirements. The role also requires the data manager to be positive, engaged, innovative and professional in their approach to their work.

This individual will have a proven history of influencing clinical data management outside of USMA, specifically collaborating with colleagues in other parts of the organizations.

1.Key Accountabilities

The accountabilities of the Clinical Data Manager include, but are not limited to:

  • Oversight of the work of the data management work conducted by the data management vendors

  • Supports data management vendors working in the FSP model in gaining access to and understanding Roche Genentech SOPs and business process documentation.

  • Conducting SAE reconciliation for the studies under their responsibility and working with members of the SMT and US Drug Safety to resolve issues

  • Ensure the Medical Teams and SMTs have prompt, complete and clear status updates on the status of the data management deliverables for sponsored studies.

  • Provides data management input to trial design and protocol development

Delivery of the Data Management Plan and associated components (including Biosample Management Plan, Data Validation Specifications, Data Quality Components and Data Review Plan)

Seeks and includes input from SMT members.

  • Working with the data management vendor to quality assure the quality and quality control (QC) of the vendor deliverables. This incorporates UAT of the clinical database.

  • Proactively and collaboratively works with the Data Engineer colleagues on the planned timing of the raw data and SDTM compliant data from the vendor database.

  • In collaboration with Data Engineer, supports delivery of tools and listings to support the Medical Teams and the SMTs in surfacing data (Patient Profiles, Data Listings etc). The data manager may be required to generate a simple listing or report using a tool such as SAS, RAVE or Spotfire.

  • Collaborates closely with Data Engineer colleagues on the timing of data delivery for PBRERs and DSURs

  • Ensuring the archiving of all data management deliverables in eTMF in a timely basis.

  • Deliver the data management contributions on sponsored studies for key initiatives such as RBM (Risk Based Monitoring)

  • Support the hiring of permanent data management staff and on-site consultants, as required.

  • Assists in on-boarding, coaching or mentoring new or less experienced team members, including on-site consultants.

  • Making an engaged contribution to delivery of the Medical Team goals.

  • Contribution to the DMD Group Meetings and making an engaged contribution towards the delivery of DMD Functional goals.

  • Creation of Annual Personal Development Plan and commitment to ensuring it's completion.

  • Being compliant with all applicable training, SOPs and Policies impacting the work of Genentech colleagues, in general, and USMA and Data Management, in particular.

  • When required, updating data core business management systems (eg Plansource, CTMS, budget management systems) with quality data, on time. Supporting the Data Management Therapeutic Area Head with data issues identified in i2V.

  • Timely submission of business expenses into the core expense management systems (Concur) for review.

  • Working with Administrative Associate colleagues, as required, to manage personal business travel.

  • Working collaboratively with Roche-Genentech data management colleagues in other divisions.

  • When required, contributing to one or more major cross-functional (within EG) or cross-USMA initiatives.

  • When required, deputize for the Data Management Head at Senior Meetings such as the DS LT, Evidence Generation Leadership Team or MLT.

  • As required, give presentations at senior management for a on the status of key projects or initiatives.

  • Work collaboratively with Program Data Managers in the other therapeutic area (Oncology or non-Oncology) and with the Data Engineer Team.

  • Work collaboratively with colleagues in other USMA Medical Units.

  • Support Data Management Head in ongoing resource estimations (headcount and spend), especially Annual resource estimations.

  • Staying abreast of internal and external developments (scientific, clinical, medical, commercial, competitive, legal, regulatory et al) which may impact the portfolio of data management work.
    2.Key Competencies / Experiences

The competencies/experiences of the Clinical Data Manager include, but are not limited to:

  • Will have at least 12 years' experience of working in the pharmaceutical, clinical research or medical device industries

  • Will have at least 8 years' experience of hands on clinical data management (database creation, study conduct and closeout etc)

  • Excellent problem solving and analytical skills.

  • Excellent presentation skills - both technical and non-technical presentations.

  • Excellent verbal and written communication skills.

  • Excellent collaborative and team-working skills, as demonstrated by working collaboratively with colleagues in other technical disciplines or at other geographical locations.

  • Proven competence of development of software under a Software Development Lifecycle (SDLC).
    3.Compliance, Audit and Quality Assurance

The Clinical Data Manager will have particular responsibility for:

  • Ensuring personal compliance to all applicable Roche SOPs, Policies and Compliance documentation.

  • Keeping personal Training and training records (eg LSO) up to date.

  • Keeping Development Plan updated.

  • Delivering programming components of internal audits (for instance, PDQA) and external audits (includes FDA and EMA Audits)

  • Managing the level of Quality Control (QC) conducted by external vendors (specifically, FSP vendors) and managing QA of the programming deliverables and QC documentation, once it arrives into Evidence Generation.
    4.External Organizations

  • Represent USMA DMD and Evidence Generation, and give presentations/chair meetings as necessary, at key external meetings such as DIA, ASCO, SCDM etc

Our Operating Principles

Put Patients First: I always act as if patients I know are in the room and do what's best for them.

Follow the science: I seek answers through experiments, data and debate, and act on facts.

Act as one team: I care, collaborate and commit without boundaries, and trust others to do their part.

Embrace differences: I seek diverse perspectives, invite opposing views, and challenge myself and others.

Accelerate learning: I push to learn new things even if difficult, and openly share my successes and failures.

Simplify radically: I eliminate complexity, reuse with pride, and accomplish more with less.

Make impact now: I take accountability to do what's right, deliver value fast, and don't wait for certainty.

Think long term: I choose actions today that benefit future generations.

For Colorado-based applicants, the expected salary range for this position is $175,000 -$185,000. Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits listed below.

Benefits

Roche offers highly competitive benefit plans and programs, including:

  • Medical, dental and vision insurance

  • 401(k) and 401(k) matching

  • Paid time off

  • Roche Long Term Incentive Plan (available at certain position levels)

For New York-based applicants, the expected salary range for this position is $167,000 - $176,000. Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits listed below.

Benefits

Roche offers highly competitive benefit plans and programs, including:

  • Medical, dental and vision insurance

  • 401(k) and 401(k) matching

  • Paid time off

  • Roche Long Term Incentive Plan (available at certain position levels)

Relocation benefits are not available for this job posting.

This position is preferably located in South San Francisco, CA, however, we welcome candidates from all US territories as working remotely is a possibility.

#medicalaffairs

#datamanagement

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.

Unless entitled to a reasonable accommodation under applicable law, employees are required to be fully vaccinated against COVID-19 in accordance with customer requirements, the company's health and safety obligations and/or applicable law or guidelines.

Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We're focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. For more information about equal employment opportunity, visit our Genentech Careers Homepage.


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Data Manager Oncology Head, US Medical Affairs

Hoffmann-La Roche Ltd