Evidence Operations Manager
Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The Position
At Roche, we are passionate about transforming patients’ lives, and we are bold in both decision and action - we believe that good business means a better world. That is why we come to work every single day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all.We do this today to build a better tomorrow. Roche is strongly committed to a diverse and inclusive workplace. We strive to build teams that represent a range of backgrounds, perspectives, and skills. Embracing diversity enables us to create a great place to work and to innovate for patients.
Objective:
The Evidence Operations Manager (EOM) provides operational expertise and oversight to the Canadian affiliate's research portfolio to ensure the successful, timely execution of strategic, innovative evidence. The EOM Oversee and manages the operational implementation of all supported studies (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.
The Opportunity:
- 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.
- Oversee operational elements of study delivery including IMP Management, tracking budget, timelines, milestones, and critical study activities, ensuring systems and maintenance of trial management tracking tools and platforms are timely and accurately maintained.
- Ensures external sponsors/stakeholders and vendor partners deliver on commitments to agreed targets; through an adherence to budget, ICH-GCP standards, Roche SOPs, and other operating guidelines and regulatory requirements as well as proactively identifying risks as applicable.
- Contributes to study management and clinical operations excellence by proactively identifying opportunities, mitigating risks and supporting continuous improvement. Provides operational input and considerations to medical affairs strategy hubs during planning, start-up, conduct of evidence generations activities.
- Proactively establishes and maintains effective working relationships with internal and external stakeholders, acts as internal and external operational point of contact for all assigned EG studies/programs and proactively establishes and maintains effective working relationships.
Who you are:
- Bachelor's Degree in a medical/science-related discipline required. Master's Degree in Science, or Post Graduate Degree for Clinical Research an asset, with a minimum of 2-4 years experience in clinical research (with either interventional study or RWD study experience), or health related industry is required.
- Strong project and process management skills: can prioritize multiple tasks and goals to ensure timely, on-target and within-budget, with a proven track record of meeting or exceeding objectives and goals.
- Strong knowledge of operational aspects of clinical trial management including ICH-GCP and other relevant standards and guidelines
- Self-motivated and results driven, highly organized with an excellent ability to prioritize own tasks and to optimize team performance. Can manage multiple tasks simultaneously and brings a solutions oriented approach.
- Strong customer focus with a proven track record of delivering results. Can work closely with multiple internal stakeholders with strong communication & presentation skills.
Preferred:
- Fluent English language knowledge, written and verbal; French speaking an asset but not required
- Strong computer / technical skills – comfort using MS Office, google based platforms, web-based systems and internal databases
- Knowledge of relevant therapeutic areas is an asset
- Financial acumen: proven abilities for effective planning, development and oversight of project budgets and other resource an asset
Relocation benefits are not available for this posting.
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.