Data Manager

Canada, Ontario, Mississauga
United States of America, California, South San Francisco

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Title: Data Manager
Division: PDB
Location: Mississauga OR South San Francisco

Duration: Full-time

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


 

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.