Job Description

The Position

Title: Evidence Operations Manager

Department: Health Data Strategy

Location: Mississauga Campus

? Job Accountabilities

Oversee and manage operational implementation of all sponsored and supported LMA Trials (including Investigator Initiated Studies), Managed and Funded Non Interventional Studies, Scientific Credibility, Post Trial Access and Pre-Approval Access in accordance with the applicable regulatory requirements and guidelines (e.g. AMG, MPG, ICH / GCP etc.) as well as applicable Roche SOPs

Managing assigned evidence generation study/program operations, and assuming accountability for such, to ensure delivery of operational activities to meet study/program timelines, requirements, deadlines, as required

Providing operational input and considerations to medical affairs strategy hubs during planning, start-up, conduct of evidence generations activities

Ensuring adherence to budget, ICH-GCP standards, Roche SOPs, and other operating guidelines and regulatory requirements

Ensuring external sponsors/stakeholders and vendor partners deliver on commitments to agreed targets; identifying risks as applicable

Contributing to study management and clinical operations excellence by proactively identifying opportunities, mitigating risks and supporting continuous improvement

Tracking budget, timelines, milestones, and critical study activities; proactively identifying issues/risks; proposing and implementing risk mitigation strategies and resolutions

Ensure systems and data maintenance of trial management tracking tools and platforms, ensuring timeliness and accuracy

Oversee IMP Management for assigned studies/programs, including tasks such as local drug label review, IMP forecasting for PTA, and IIS projects, expiry dating, receiving/raising IMP requests, and IMP reconciliation/destruction, corresponding with all internal and external stakeholders as necessary

Provide vendor oversight and management during project lifecycle

Provides operational expertise to partnering/collaborations where research may play a part within the overall partnership

Ensure due diligence of study budgets within fair market value. Liaise directly with external stakeholders during budget negotiations

Ensures external stakeholder compliance with the safety reporting activities for IIS, PAA, PTA and ensures reporting timelines are met

Support Health Data Strategy Lead, Operational Excellence Lead, Strategic Collaborations Lead with evidence generation strategy and planning activities.

Stay current on relevant therapeutic knowledge for assigned disease areas and clinical research best practices

Participate in appropriate global/affiliate networks/communities for best practice sharing and leveraging insights that impact the activities within the Evidence Generation Chapter

Proactively establish and maintain effective working relationships with internal and external stakeholders

Maintain awareness of affiliate/global networks and resources available to support Evidence Generation Chapter activities

Provide operational input/considerations during feasibility planning stages of Evidence Generation Chapter activities

Develop and maintain strong communication plan with internal and external stakeholders where we are executing EG activities

Compliantly cultivating and maintaining productive relationships with relevant internal and external partners/stakeholders

Act as internal and external operational point of contact for all assigned EG studies/programs

Manage study proposal and protocol review and approval processes, ensuring appropriate cross-functional resources are assigned

Partner with Site Contacts on development of site budget template and budget negotiations

Coordinate planning and execution of effective meetings with internal study/program teams, external investigators and vendors (i.e. study planning, kick-off meetings, progress updates, etc). As appropriate/applicable, drive agenda and content for these meetings

Requesting, receiving documents for clinical research from study start-up to close down, such as ethics approvals, Health Canada approvals, etc.

KNOW-HOW

? Education / Skills / Knowledge / Experience Required

Bachelor's Degree in a medical/science-related discipline required

Master's Degree in Science, or Post Graduate Degree for Clinical Research an asset

A minimum of 2-4 years experience in clinical research (with either interventional study or RWD study experience), or health related industry is required.

Fluent English language knowledge, written and verbal; French speaking an asset but not required

Strong project and process management skills: can prioritize multiple tasks and goals to ensure timely, on-target and within-budget accomplishment of such

Strong computer / technical skills - comfort using MS Office, google based platforms, web-based systems and internal databases

Strong knowledge of ICH-GCP and other relevant standards and guidelines

Strong knowledge of operational aspects of clinical trial management and the drug development process an asset

Knowledge of relevant therapeutic areas an asset

Proven track record of meeting or exceeding objectives and goals

Good communication & presentation skills: communicates in a timely, thorough and concise manner and is comfortable presenting information to others at varying organizational levels

Strong interpersonal & partnering skills: has proven abilities to work effectively and efficiently in cross-functional, often virtual and matrix teams

Financial acumen: proven abilities for effective planning, development and oversight of project budgets and other resource an asset

Qualified candidates are encouraged to submit cover letter and resume no later than October 26, 2022.

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.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

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.

As of January 4, 2022, Roche requires all new employees who work in Canada to be fully vaccinated against COVID-19 on the date they take office. This requirement is a condition of employment at Roche that applies regardless of whether the position is on a Roche campus or remotely. If you have a valid reason for not being fully immunized, which is limited to certain specific medical reasons or other valid reasons protected by applicable human rights laws, you may request an exemption and / or adaptation measures regarding this vaccination requirement.

Roche is an Equal Opportunity Employer.