Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • Ontario

Description

Data Manager


Ontario,
Canada


Job ID: 201912-134939


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The Position


Title: Data Manager

Division: PDB

Location: Mississauga & South San Francisco

Duration: Fulltime


Responsibilities:

• Collaborate with peers within the function and across the organization to identify, design and

execute fit for purpose data management solutions, ensuring FAIR principles are adhered to.

• Act as experts for data collection and acquisition, advising teams and stakeholders on best

practices and proposing innovative solutions. e.g. the collection of new data types (e.g.

emergent biomarkers), new technologies (e.g. sensors), and new data sources (e.g. RWD,

EMR).

• Partner with and provide oversight of data management deliverables (e.g. Work-Packages) to

our Functional Service Providers (FSPs) and vendors. Provide Quality Assurance on tasks as

applicable to ensure a high quality of data and compliance with applicable pharma industry

regulations and standards.

• Proactively manage timelines and track decisions, ensuring successful delivery of the study

work packages carried out at FSPs. Continue to be accountable for quality and where needed,

provide support in the form of business and technical expertise to our FSPs.

• Oversee FSP in Sample management and eManifest process, ensuring timely, proactive

resolution of queries.

• Provide high level review of data using graphical visualizations, statistical monitoring tools,

and standard metrics designed to identify outliers or trends in data received, gaps in standard

checks programmed or other unexpected anomalies in the data.

• As required, be the Biometrics rep on the new ReImagineSMTs (SLT triad, currently late

phase only) and any associated meetings such as Data Quality meetings. At a minimum, act as

the CDM rep for PDB and SLT. Inform stakeholders of status of key deliverables and

milestones.

• Proactively engage with stakeholders across the business and biometrics to understand their

needs and influence their understanding of decisions made on our function.

• Partner with relevant functions for external data vendor selection and management.

• Oversee development of data transfer agreements with vendors ensuring use of standards, fit-for- purpose data models and transfer intervals.

• Contribute to functional, cross functional, enterprise-wide or external initiatives that shape our

future landscape.

• Contribute to clinical coding strategies; oversee the coding activities performed by the FSP.


Skill Set:

• PROJECT MANAGEMENT : Develop risk management strategies and proactively manage

timelines to ensure successful oversight and delivery of studies, projects and coding

responsibilities, including the implementation and adoption of new technologies.


• STAKEHOLDER MANAGEMENT: Proactively engage with stakeholders across the

business to understand their needs and influence their understanding of decisions made in our

function. Inform stakeholders of status of key deliverables and act on changing milestones.


• VENDOR MANAGEMENT: Partner with relevant functions for external data vendor

selection and management. Oversee development of data transfer agreements with vendors

ensuring use of standards, fit-for-purpose data models and transfer intervals.


• DATA COLLECTION AND ACQUISITION: Act as experts for data collection, advising

teams and stakeholders on best practices and proposing innovative solutions. Ensure a high

quality of data and compliance with applicable pharma industry regulations and standards.

• PROVIDE DATA SOLUTIONS: Stay current with and adopt emergent data collection, data

management, visualization and provision tools and applications to ensure fit-for-purpose and

impactful approaches. Deliver on solutions as needed.


• DATA QUALITY REVIEW : Use data surveillance tools and strategies to provide aggregate

level reviews designed to identify patterns or anomalies in our data to ensure high quality

results.

• DATA CURATION: Organization and integration of data collected from various sources.

Maintain value of data through application of FAIR (Findable, Accessible, Interoperable,

Reusable) principles.


• SUPPORT ANALYSES: Partner with stakeholders to understand their data insight needs and

offer Data Management solutions. Demonstrate a strong understanding of the data flow from

collection through to analysis and filing.


• FUNCTIONAL EXCELLENCE : Collaborate and contribute to functional/cross-functional

initiatives or goals to promote new ways of working, including emerging technologies. Enable

broader and more effective use of data to support the business.


• TECHNICAL CONSULTANT : Offer guidance and advice to peers within the function, to

key stakeholders and to FSPs, CRO and collaborative groups on technical solutions to ensure

high quality data collection and delivery. Deliver on solutions as needed.


Requirements:

• BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics OR equivalent industry

experience.

• Strong collaboration and excellent communication skills – both written and oral

(proficiency in English required).

• Knowledge of CDISC data standards

• Knowledge of ICH-GCP and working in regulated environments.

• Project Management skills.

• Able to manage multiple requests and priorities.

• Demonstrated leadership capabilities around decision-making, negotiation, motivation (self

and others) and influencing.

• Experience with data analytics and/or visualization tools and techniques.

• Demonstrated entrepreneurial mindset and self-direction, ability to mentor others and

willingness to learn new techniques.

• Knowledge of biological principles, display interest and demonstrate scientific curiosity

including an understanding of data types and their scientific use (​clinical, biomarker,

WGS, RNA-seq, etc.).


Preferred Requirements:

• Experience in leading CDM study teams and maintaining oversight of all start-up, conduct

and close-out activities for multiple or complex studies, ensuring fit for purpose quality

(including oversight of FSPs, Vendors, CROs and Collaborative Groups).

• Experience in leading the collection of clinical trial and/or Real World Data.

• Good understanding of molecule and disease area strategies, healthcare environments, as well

as strong scientific and technical expertise.

• Experience with SDTM implementation and CDISC standards.

• Experience with standardized terminologies such as MedDRA and WHODrug


This position is not eligible for relocation support.

This position is open to applicants legally authorized to work in Canada or USA


Qualified candidates are encouraged to submit cover letter and resume no later than December 18, 2019.


NOTE: All employment is conditional upon the completing and obtaining a satisfactory background check, including educational, employment, references and criminal records (for which a pardon has not been granted) checks.

Roche is an equal opportunity employer and prohibits unlawful discrimination based upon any legally protected ground. Roche will make a good faith effort to accommodate the individual needs of applicants with disabilities in our recruitment process


AGENCY NOTICE: Please note that Roche Canada does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Services Agreement with agency/recruiter, Roche Canada will not consider or agree to payment of any referral compensation or recruiter fee. In the event a recruiter or agency submits a resume or candidate without a previously signed agreement, Roche Canada explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.


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.


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About the company

Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. We are among the world's leading biotech companies, with multiple products on the market and a promising development pipeline.