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Clinical Scientist

USWM, LLC
Philadelphia, PAPosted 4 days ago

Job Description

The Clinical Scientist role is a global role, based in the US. The role provides scientific and operational input and oversight, as well as leadership and management of cross-functional execution of clinical trials. 


The Clinical Scientist will be responsible for leading global clinical trial delivery including the planning, management and reporting of trials in accordance with company plans/objectives, GCP, local country requirements and company standard operating procedures. This includes leading cross-functional Study Conduct Teams, writing and/or reviewing protocols and other study related documents, country/site selection, start up, study conduct and oversight, data review, and study close-out, for one or more clinical trials. 

DUTIES AND RESPONSIBILITIES: 

The following reflects management’s definition of essential functions for this job but does not restrict the tasks that may be assigned. Management may assign or reassign duties and responsibilities to this job at any time due to reasonable accommodation or other reasons.

  • Support study design, translate scientific imperative into operational delivery of trials. Review and/or writing of study concept, protocol, study plans, CSRs, publications
  • Lead the cross-functional Study Conduct Team; drive operational delivery and facilitate issue resolution
  • Plan and maintain timelines, conduct study feasibility, risk assessment/management and contingency planning. Ensure timelines are communicated to all team members assigned to the study (including vendors)
  • Develop and maintain effective relationships with clinical sites and KOLs globally. Lead Site/Investigator meetings and represent study team at industry conferences as needed.
  • Provide guidance on protocol and procedures in the development of eCRF design.
  • Liaise with monitors to identify trends on data management issues/ICF issues/quality issues/ investigator site file (ISF) issues/site staff issues to develop solutions.
  • Review clinical trial data; monitor data quality and ensure appropriate quality measures are in place to identify any issues with data metrics and data integrity.
  • Support and review of study and site budgets, including vendors contracts, POs and invoice approval. 
  • Study specific vendor oversight, interaction and coordination in conjunction with cross-functional team members, as appropriate.
  • Liaise with treatment operations, logistics and manufacturing teams to ensure subject treatment co-ordination.
  • Ensure cross-functional maintenance of TMF and inspection readiness activities are completed.
  • Proactive stakeholder management and communication of progress, risks and issues.
  • May provide mentoring of other members of CDO/company as applicable.
  • Contribute to process improvement initiatives including SOP writing/revision, Guidance Documents, workstreams, etc.


QUALIFICATIONS: 

  • Minimum of a BA/BS in Life Sciences Degree
  • Previous leadership in a matrix environment
  • 4-7+ years of industry-sponsored clinical trial management experience.
  • Strong knowledge of clinical operations and the regulatory process - experience independently leading/managing multiple clinical trials 
  • EDC experience including trial management, data review, issuing and resolving queries, CRF design/review/ approval
  • Experience with clinical protocol development and/or regulatory submissions and management 


The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

PHYSICAL DEMANDS:

  • Frequently required to stand
  • Frequently required to walk. 
  • Frequently required to sit. 
  • Frequently required to talk or hear. 
  • Occasionally required to lift light weights (less than 25 pounds) 
  • Specific vision abilities required for this job include: close vision, color vision and ability to adjust or focus
  • May require travel


WORK ENVIRONMENT: 

  • The noise level in the work environment usually is quiet.


Equal opportunity employer, and does not discriminate on the basis of race, color, religion, sex, pregnancy, national origin, disability, age, genetic information, veteran status, sexual orientation, gender identity or any other characteristic protected by federal, state or local law.

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