Manager, Site Selection

5 months ago

Montréal, Canada Innovaderm Research Full time

The Manager, Site Selection supervises the site selection personnel and all site selection related activities to ensure they are conducted to the Sponsor’s satisfaction, in accordance with applicable standard operating procedures (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 new and existing team members; plans and assigns work; oversees the performance of direct reports and performs annual reviews; guides professional development; addresses employee relation issues; escalates issues and communicates project risks to Senior Management, as necessary.
- Ensures adequate training and consistent use by the internal team members of SOPs and Tools related to sites selection activities
- Ensures that projects are completed to the Sponsor’s satisfaction, ensuring quality deliverables on time, within budget and in accordance with applicable standard operating procedures (SOPs), regulatory and good clinical practices (GCP)
- Provides support, as needed, to site budget and contract negotiations and strategies to ensure overall investigator study budgets are within expectation
- Works in collaboration with project teams to identify quality issues related to sites performance through project meetings, escalation of site communications, and quality assurance audit findings
- May serve as a primary point of contact for Sponsors when issues must be escalated to ensure communication is maintained and resolution is achieved. Reports to Senior Management, if necessary
- Ensures the site selection team understands the hours allocated to each study activity and
- estimate hours/cost to complete. Ensures team member accountability for hours billed to each task vs level of task completion
- Identifies areas of excess billing with direct reports and resolves the issues
- Participates in proposal requests by overseeing prefeasibility outreaches, development of site selection strategies, and presentation at bid defense meetings
- Develops global site network relationships
- Develops and manages Business-to-site marketing initiatives to foster new working relationships with sites
- Develops maintenance strategies and oversees activities related to the investigators database to support site identification and selection
- Identifies potential areas for improvement and leads process improvement initiatives to optimize workflow and tools
- Supervises/coordinates CRA resources allocation required for site qualification visits
- Supervises/participates in sites selection including review of site qualification visit summaries
- Recommends/approves sites for participation in the study, in consultation with the Sponsor and the project team, as necessary
- Ensures adequate training and consistent use by the internal team members of SOPs and Tools related to sites selection activities
- Ensures project budget and timelines are met (i.e., site identification, feasibility assessment,)
- Works in collaboration with project teams to identify quality issues related to sites performance through project meetings, escalation of site communications, and quality assurance audit findings
- Responsible for the management and improvement of departmental key performance indicators (KPIs)
- Participates in Sponsors and regulatory agency audits as required
- Authors, reviews and updates related SOPs and Tool as necessary
- May perform other tasks in order to fulfill project requirements, as needed

**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 has worked closely with sites or worked in a site environment
- Prior experience in development of process improvement initiatives, assets
- Experience of dermatological clinical research is a definite asset
- Departmental management experience is an asset

**Knowledge and skills**
- Excellent written English skills
- Written and spoken fluency in additional languages (particularly Polish, Spanish, German and French) an asset
- Excellent knowledge of Microsoft Office suite (Word, Excel, Power Point)
- Quick learner, good adaptability and versatile. Strong troubleshooting skills
- 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 pace and evolving environment
- Flexibility, positive attitude, superior attention to detail, and critical thinki

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