2018-12-07

BIOSAMPLE OPERATIONS SPECIALIST
Job Opportunity at Clinical Dynamix, Inc.

Posted on Dec 7

http://www.clinicaldynamix.com    561-732-4505

Location: New York City, NY
Job Type: Full Time
Job ID: W4174730

BIOSAMPLE OPERATIONS SPECIALIST
Drives alignment of study and project level strategies within the overarching therapeutic area strategy for biosamples, through close partnership with the Biosample Therapeutic Area Leaders (BTALs), service providers (including lab vendors) and DTA stakeholders
  • Is responsible for the delivery and implementation of the biosample strategy within multiple clinical programmes in accordance with the requirements of quality, ethical and regulatory standards including ICH/GCP/GLP
  • Ensures project level consistency for biosampling across studies and is the primary point of contact within Biosample Operations for project, clinical and study teams
  • Delivers expert input on strategic direction and operational considerations for Biomarker sampling to project and study teams
  • Leads or contributes to innovation and  continuous improvement activities in the area of biosample  collection, processing and data delivery
Primary Responsibilities and Accountabilities:
  • To provide operational expertise to ensure the successful   implementation of the biosample strategy for a given molecule or clinical program
  • To ensure the appropriate level of sample quality, defining corrective actions if necessary, and acting as a point of escalation for issues at the study and project levels
  • To implement the biosample sourcing strategy within given projects through partnership with the BTAL and other key stakeholders involved in project and study delivery
  • To be accountable for project level oversight (from feasibility to study close) of laboratories/vendors and associated costs involved in biosampling activities and analyses. Provides input to the laboratory selection process to ensure appropriate vendor selection where applicable
  • Leads cross-functional operations team meetings as required to ensure optimal delivery of project biosampling objectives
  • To actively promote knowledge sharing within Clinical Operations and across studies within a project by partnering with stakeholders.
  • To be accountable for the accurate and timely forecasting and management of individual project and study variable costs related to bio-sampling, in collaboration with key stakeholders
  • To provide regular project/study level biosample status updates to key stakeholders as required.
  • To act as a subject matter expert within the Clinical Operations for specific business related topics or processes
  • To contribute to, and occasionally lead, functional  process and system improvements to ensure operational excellence
  • Mentor others as required to maximise their capability and contribution to deliver high quality biosamples
  • Partner with cross functional parties and external vendors to communicate and train on relevant processes which underpin the laboratory operating model
  • To contribute to a positive and motivating work environment that encourages mutual respect, innovation and accountability at all levels through role modelling the company values of courage, passion and integrity
  • Ensures implementation of the ethical and legal framework for biosampling
These statements are not intended to be an exhaustive list of all responsibilities, duties, and skills required of people assigned to this job, but are instead intended to describe the general nature and level of the work.  Different levels of responsibilities & accountabilities may be assigned to take account of the skills capabilities and experience of the individual.
 
Education / Qualifications:
Minimum:
  • Life sciences degree or equivalent qualification
Experience, Skills, Knowledge
  • Significant experience implementing clinical trials - required
  • Extensive experience in leading and managing biosample operational activities on a range of logistically complex multi-centre clinical studies, - preferred
  • Demonstrated knowledge of ICH GCP
  • Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples
  • Demonstrated leadership skills
  • Proven ability to successfully achieve results within a multi-cultural and geographically diverse matrix environment
  • Proven ability to influence effectively and confidently within a matrix environment
  • Knowledge of legal and regulatory environment related to human specimen collection, analysis and retention
  • effective communication skills
  • ability to lead and work across a global matrix team and stakeholder environment
  • ability to work independently and manage multiple competing priorities
  • effective strategic agility
  • ability to work with internal and external partners
  • Excellent written and spoken English.
  • Willingness to travel internationally and work cross-culturally
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