Study Data Manager (Clinical Research)

Job description

  Job facts

Title: Study Data Manager
Department: Clinical Data Management
Location: Mississauga Campus

Multiple Positions

Objective:

To serve as the core representative for Clinical Data Management (CDM) on the study team and to be accountable for collection, review and management of data and ensure deliverables are met.

Responsibilities:

1. Leads the Clinical Study Team

·  Maintains oversight of all activities for one or more studies to ensure productivity and progress
·  Manages lab reference ranges and processes
·  Participates in the oversight and prioritization of work of Clinical Research Organizations (CROs) to ensure efficiency
·  Effectively communicates ideas, project goals and status of work and independently presents at department meetings to ensure team is up-to-date

2. Contributes or leads local and subfunctional working groups and initiatives

·  Liaises with Program Data Management (PDM) across one or more CDM study teams in order to implement standards
·  Occasionally performs program-level activities for molecules where a Program Data Leader (PDL) is not assigned in order to ensure process is monitored
·  Provides input during protocol review to ensure PDM components are included and comprehensive
·  Responsible for complex deliverables for the subfunction for one or more studies
·  Communicates study timelines and deliverables to all CDM study team staff and follows up to ensure timely delivery of assigned tasks
·  Leads or participates in the local functional/cross-functional implementation of best practices and process improvement initiatives
·  Provides PDM study specific training to CDM staff, including service providers to ensure valid outcomes
·  Actively participates in study debrief meetings, shares learnings with CDM staff and participates in subsequent best practice implementation in order to keep employees up-to-date

3. Problem Solving

·  Escalates study issues appropriately and addresses corrective action plans
·  Identifies and develops solutions to complex problems to ensure issues are resolved effectively and in a timely manner
·  Sets targeted timeframes for deliverables and anticipates potential scenarios that may create timeline delays; able to influence and negotiate a positive outcome
·  Evaluates probability, impact and priorities of risks and develops and implements mitigation plan

·  Who we are

Roche Pharma Canada has its office in Mississauga, Ontario and employs over 850 employees.The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche's truly innovative culture.

Roche is an equal opportunity employer.

Desired profile

Who you are

You're someone who wants to influence your own development. You're looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

Qualifications:

·  A minimum of 4 year Science (Biological Science) degree or equivalent in scientific, medical or relevant clinical discipline or a qualified healthcare professional required
·  CCDM (Certified Clinical Data Manager through the Society for Clinical Data Management (SCDM) preferred
·  A minimum of 2 – 5 years' experience
·  Moderate practical and theoretical expertise within the subfunction
·  An understanding of the business of his or her subfunction and greater CDM organization
·  Ability to work under minimal guidance
·  Functional knowledge in the development of subfunctional processes, training and related documents
·  Technical proficiency and ability to complete complex assignments within defined parameters
·  Ability to partner with PTM training community to ensure best training practices are being leveraged in focused training
·  Ability to identify a range of problems and escalate appropriately
·  Contribution to the awareness and education of fellow subfunctional colleagues by sharing information and learnings from attendance at conferences and educational enrichment activities
·  Ability to represent at industry user groups and conferences leveraging net-working opportunities

Qualified candidates are encouraged to submit cover letter and resume no later than April 16 2018.

This position is not eligible for relocation support.
This position is open to applicants legally authorized to work in Canada.

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.

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