Lead Clinical Data Manager

Found in: Talent CA 2A C2 - 2 weeks ago


Toronto, Canada SCiAN Services Full time

Exceptional opportunity to work with growing and successful CRO


About Scian

 

SCiAN Services is a Contract Research Organization offering expertise-based services in the Biotechnology/ Pharmaceutical Industry. SCiAN serves well known companies by providing high quality deliverables and superior customer service. For over 34 years we have embraced innovation when offering services in Pharmacovigilance, Biostatistics, Data Management and Custom Database Solutions. SCiAN’s therapeutic expertise includes immuno-oncology, gene therapy, CNS, infectious disease, autoimmune diseases and diabetes.


www.scian.com


Job Summary

 

SCiAN Services offers employees exceptional opportunities for growth and exposure within the company itself. In your position, you will be introduced to all areas of expertise ranging from Biostatistics to Data Management to IT. SCiAN’s employees learn in a hands-on, personalized environment, and are able to achieve more as a result.


To support the Company’s growth, we are seeking to add Lead Clinical Data Manager to our team. 

 

  Key Accountabilities:

  • Responsible for overseeing employee training and development to ensure optimal performance, compliance with SCiAN systems and processes, as well as development of effective leadership skills
  • Support career development, provide performance feedback, communicate team & individual goals as well as expectations and promotes a positive work environment.
  • Review project tasks and timelines, determine the level of resources and resource projections to ensure project teams are consistent with client needs, expectations and contractual expectations.
  • Prioritize the accurate forecasting of project revenue as well as revenue recognition throughout the entire CDM team
  • Ensures that CDM activities are performed to the Sponsor’s satisfaction, ensuring timely quality deliverables, within budget and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices, as well as study-specific requirements.
  • Provide leadership and implement CDM services and productivity improvements to ensure optimal utilization of billable resources by collecting metrics and leading task forces to implement process improvement initiatives.
  • Co-chair CDM review meetings to identify issues and implement contingency plans and strategies to ensure projects are conducted to the utmost level of quality, ensuring compliance with study budget, timelines and company goals.
  • Write, review and update related SOPs and TOOLs.
  • Provide input on the preparation of requests for proposals (RFPs) and request for information (RFIs) for new studies including preparation of budgets. Participate in proposal defense meetings.


Qualifications and Experience: 

  • B.Sc. in a field relevant to clinical project management.
  • Minimum of 8 years of combined experience in clinical and project management in the biotechnology, pharmaceutical, or CRO industry, including a minimum of 5 years in a leadership capacity in project management/clinical research;
  • Experience in a CRO is an asset.

 

Knowledge and skills:

  • Excellent oral and written English skills.
  • Excellent mastery of Microsoft Office suite (Word, Excel, Power Point);
  • Ability to work in a fast-paced evolving environment and establish good relationships with colleagues and sponsors;
  • Quick learner, good adaptability and versatile;
  • Excellent leadership, judgement, soft and problem-solving skills;
  • Strong organizational, communication, time management and multi-tasking skills;
  • Good knowledge of good clinical practices, and applicable local and international regulations/guidelines.


Candidates must be eligible to work in Canada.

To find out more about SCiAN Services and to review other opportunities, please visit our website at www.scian.com.


We thank all interested applicants, however, only those selected for an interview will be contacted.



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