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Manager, Site Selection
2 weeks ago
The Manager, Site Selection supervises the site selection personnel and all related activities to ensure they are conducted to the Sponsor's satisfaction, in accordance with SOPs, regulatory, good clinical practices and study-specific requirements. The Manager, Site Selection maintains departmental oversight and development to meet company needs.
RESPONSIBILITIES
More specifically, the Site Selection Manager:
- Oversees the management and development of site selection personnel: recruits new resources based on company needs; manages onboarding process for new employees; ensures adequate training of team members; plans and assigns work; oversees performance of direct reports and performs annual reviews; guides professional development; addresses employee relation issues; communicates project risks to Senior Management, as necessary
- Ensures training and consistent use of SOPs and Tools related to sites selection activities
- Ensures projects are completed to the Sponsor's satisfaction, ensuring quality deliverables on time, within budget and in accordance with SOPs, regulatory and good clinical practices
- Provides support to site budget and contract negotiations and strategies for investigator study budgets
- Works in collaboration with project teams to identify quality issues related to sites performance; escalates site communications, and quality assurance audit findings
- Serves as a point of contact for Sponsors when issues must be escalated; ensures communication is maintained and resolution is achieved; reports to Senior Management, if necessary
- Ensures team accountability for hours billed to each task vs level of task completion
- Identifies areas of excess billing with direct reports
- Participates in proposal requests; oversees development of site selection strategies and presentation at bid defense meetings
- Develops global site network relationships and Business-to-site marketing initiatives
- Develops maintenance strategies related to investigators database to support site identification and selection
- Identifies potential areas for improvement and leads process improvement initiatives
- Supervises/coordinates CRA resources allocation for site qualification visits
- Participates in sites selection including review of site qualification visit summaries
- Recommends/sites for participation in the study; in consultation with the Sponsor and the project team, as necessary
- Ensures project budget and timelines are met
- Responsible for management and improvement of departmental KPIs
- Participates in Sponsors and regulatory agency audits as required
- Authors, reviews and updates related SOPs and Tool, as necessary
- May perform other tasks as needed to fulfill project requirements
IDEAL PROFILE
Education
- B.Sc. or in a relevant field of study
Experience
- Minimum of 6 years' experience in clinical research in the biotechnology, pharmaceutical, or CRO industry, including significant and relevant experience in site selection, study start-up activities and/or working closely with sites
- Prior experience in development of process improvement initiatives
- Experience of dermatological clinical research is a definite asset
- Departmental management experience is an asset
Knowledge and skills
- Written and spoken fluency in additional languages an asset
- Excellent knowledge of Microsoft Office suite
- Quick learner, good adaptability and versatile
- Ability to work in a team environment and establish good relationships with colleagues, sponsors, and sites
- Organized, able to juggle competing priorities, and work in a fast-paced and evolving environment
- Flexibility, positive attitude, superior attention to detail, and critical thinking skills
- Good knowledge of regulations and guidelines as applicable
OUR COMPANY
The work environment
At Innovaderm, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability, and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.
In this position, you will be eligible for the following perks:
- Permanent full-time position
- Complete benefits
- Possibility of working from home in accordance with company policies and public health directives
- Ongoing learning and development
About Innovaderm
Innovaderm is a contract research organization specialized in dermatology with a strong reputation for quality research and services. Based in Montreal, Innovaderm continues to grow in North America and Europe.
Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
Innovaderm only accepts applicants who can legally work in Canada.
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