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Manager, Clinical Research

Req #: 16001614
Location: Mississauga, ON CA
Job Category: Clinical Development
Work Location: Mississauga, Ontario 6755 Mississauga Road Suite 600 Mississauga L5N 7Y2
Organization: Celgene Inc.
Schedule: Full-time
Shift: Day Job
Employee Status: Regular
Job Type: Standard
Job Level: Manager
Travel: No

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

 

The Position:

Clinical Research Manager:

The Clinical Research Manager is responsible for supporting the execution of high quality clinical research for Celgene sponsored trials according to ICH/GCP guidelines and local regulations by:

  • Supporting global study teams as required
  • Partnering with Clinical Research Organizations (CRO) at a local level
  • Oversight of clinical monitoring group to assure adherence to high quality GCP standards
  • Working cross-functionally with applicable local functions
  • Acting in the capacity of local compliance advisor for global clinical trials

Responsibilities include, but are not limited to:

1) Collaborate with Global Study Teams and CRO partners to ensure timely, accurate  feedback throughout the conduct of the trial

  • Primary point of contact to support planning and execution of Celgene-sponsored clinical trials (phase’s I-IV)
  • Responsible for project leadership and site relationship management of pre-defined Clinical Trial Partner sites to support optimization of key processes and to ensure critical trial milestones/timelines are being met
  • Have a comprehensive overview of all Celgene sponsored clinical study activities in Canada
  • Support the Feasibility process of clinical programs and studies in collaboration with Global Clinical Research Development Operations and CRO partners, as appropriate:
    • Country / Site Feasibility: Ensure process is conducted in the most expeditious manner including appropriate recommendations for sites based on prior performance, protocol design and local input
    • Conduct Pre-Study/Feasibility Assessments as required supporting Optimal Selection of Sites for participation
  • Start-up Activities: Support CRO in terms of moving site approvals process along with a view to improve benchmarking timelines in collaboration with our Key sites and Partner Institutions. Support coordination, planning and attend Investigator Meetings as appropriate
  • Conduct/Closure:  Provide solution based approaches to potential challenges during conduct with respect to recruitment, data cleaning and site responsiveness
  • Expedite negotiation of contracts/clinical trial agreements together with contracts team
  • Identify and support implementation of process improvements for contract/budget negotiation
  • Mitigate issues that arise with respect to site payments

2) Oversight of clinical monitoring group to assure adherence to high quality GCP standards

  • Manage direct reports within the clinical research team, interviewing and hiring new employees, establishing team and individual goals, and performing annual reviews
  • Provide support for Individual Development Plans to ensure individuals are current with respect to SOPs and regulations
  • Tracking of workload and assessment of needs to plan for future resources according to demands of the clinical programs

3) Communication of Trial Progress and Escalation of Key Issues

  • Support identification, escalation and resolution of issues related to study conduct (eg. key performance indicators, site conduct/responsiveness, data quality etc.)
  • Provide regular trial updates to Medical Affairs Therapeutic Teams
  • Support preparation of presentations for Therapeutic Teams and Leadership Teams

4) Coordination and support drug supply for Global Business Partner/Alliance Trials

  • Work with Global Technical Operations Alliance Management and drug supply depots/pharmacies to support initiation and ongoing drug supply for pre-defined trials
  • Track and communicate issues/changes to expected patient volumes in support of business planning and financial forecasting across all therapeutic areas

5) Act in the capacity of local Compliance Advisor and Trainer

  • Keep informed on relevant local regulations and laws and communicate to applicable personnel, as appropriate
  • Ensure appropriate personnel have comprehensive knowledge of relevant local regulations and laws including any amendments, as required
  • Create New and Update Local Work Practices as required
  • Implement training programs for work practices to ensure alignment cross-functionally
  • Perform local oversight visits (SMART Visits) that include a quality review of clinical trial documentation and the assessment of the performance of field monitoring activities, as needed
  • Perform other duties as assigned by local management

Qualifications
Skills/Knowledge Required
  • Extensive experience in the pharmaceutical/medical field with at least 5 years of clinical trial management/monitoring experience recommended
  • Scientific/healthcare related degree
  • Relevant therapeutic area experience desirable
  • Excellent knowledge of regulations that apply to clinical studies
  • Strong leadership skills essential
  • Effective team building and teamwork skills
  • Ability to prioritize and manage time efficiently
  • Excellent written and verbal communication and interpersonal skills. Must be able to relate effectively to people at all levels of the organization
  • Working knowledge of SOPs/regulations relevant to clinical research
  • Fluent in written and spoken English
  • Computer literate; familiarity with Microsoft Office programs, in particular, Word and Excel
  • Financial and business awareness

Behaviours

  • Demonstrate character through Courage, Integrity and Honesty
  • Support and lead change by keeping a strategic perspective, driving innovation and applying a global mind-set
  • Achieve results by acting quickly and decisively and taking appropriate risks
  • Inspire and motivate by developing positive relationships through open communication and fostering teamwork

 

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About Celgene

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.

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