Manager, Clinical Operations
Manager, Clinical Operations
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Job Description
Joining AbbVie means you will be part of a team of outstanding professionals dedicated to making a remarkable impact on patients lives. At AbbVie we conduct ground-breaking science on a global scale every day. AbbVie Canada is one of the Best Workplaces in Canada.
When choosing your career path choose to be remarkable.
AbbVies mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples lives across several key therapeutic areas: immunology oncology neuroscience vision care virology womens health and gastroenterology in addition to products and services across its Allergan Aesthetics portfolio.
Join AbbVies Medical Operations Department as a Manager for Clinical Operations in Non-Interventional Research. Under the leadership of the Head of Medical Operations you will play a pivotal role in overseeing the planning implementation and management of non-interventional studies. Your contribution will ensure that these research activities comply with regulations and guidelines while meeting study objectives timely and within budget.
Location: This position is head-office based (iminimum 3 days presence in office per week).
Key Responsibilities
- Lead and manage all operational aspects of non-interventional research studies from planning through execution to study closeout.
- Serve as the primary point of contact for internal stakeholders external partners and vendors associate with non-interventional research projects.
- Oversee study site payments through vendors including budget estimates and financial monitoring.
- Develop and maintain dashboards reports and KPIs to track the progress and performance of non-interventional studies providing regular updates to management and stakeholders.
- Conduct vendor assessments for Contract Research Organizations (CROs).
- Oversee management of electronic Trial Master Files (eTMF) archiving and NIS contracts.
- Mentor and develop team members including Study Coordinators and Publication Coordinators.
- Update local procedures within the Medical Department in accordance with AbbVies global guidelines and local regulations in collaboration with departmental managers.
- Stay informed on industry trends innovations and best practices in non-interventional research.
- Plan and develop strategies for both internal and external audits ensuring audit readiness through periodic reviews of relevant procedures.
Qualifications :
Qualifications
- Education: Bachelors degree or equivalent in a health-related field (e.g. Nursing Pharmacy Scientific Medical preferred).
- Minimum of 5 years of experience in clinical operations specializing in non-interventional or observational research.
- Strong understanding of GCP regulatory requirements and SOPs in clinical research.
- Proven ability to manage complex research projects within a pharmaceutical biotechnology or CRO environment.
- Excellent project management skills including expertise in budget management and resource allocation.
- Strong interpersonal and communication skills with the capacity to effectively engage various stakeholders.
- Ability to work independently and collaboratively exhibiting strong organizational and problem-solving skills.
AbbVie strives to provide a French working environment for its employees in Quebec. Although as part of its francization program has taken all reasonable steps to avoid imposing the following requirement advanced amount of knowledge of English / Fluency in English is an essential requirement for the position of Clinical Operations Manager including but not limited to for the following reasons:
- English speaking employees outside the province of Quebec.
- English speaking clients outside the province of Quebec.
- Anglophone region outside the province of Quebec.
AbbVie is an equal opportunity employer and encourages women Aboriginal people persons with disabilities and members of visible minorities to apply.
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Employment Type
Full-time
