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Sr. Clinical Data Team Lead
Sr. Clinical Data Team LeadUshitecsolutions • Boston, MA, United States
Sr. Clinical Data Team Lead

Sr. Clinical Data Team Lead

Ushitecsolutions • Boston, MA, United States
[job_card.variable_days_ago]
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  • [job_card.full_time]
[job_card.job_description]

Core Responsibilities

  • Apply relevant components of the project protocol to daily tasks and guide others on their application.
  • Serve as an interdepartmental and client liaison for all data management study activities.
  • Produce project-specific status reports for management, Project Lead, and / or clients regularly.
  • Monitor and analyze study metrics; escalate per the organization's risk management processes.
  • Participate in business development activities, including bid preparation and representation at bid defense meetings when required.
  • Assist with project forecasting of hours and identification of resource requirements.
  • Support oversight of project budgets, including identifying potential out-of-scope work and participating in the Contract Modification process.
  • Lead high volume / highly complex studies, delegating tasks to ensure timely completion of project activities within project, quality, and budget requirements.
  • Mentor junior staff on all study-associated tasks.
  • Assist with administrative and financial oversight for allocated projects.
  • Communicate regularly with management regarding data management progress and challenges.

Qualifications

  • Bachelor's degree (BS) or equivalent, with relevant formal academic / vocational qualification.
  • 5+ years of relevant experience providing the knowledge, skills, and abilities to perform the job.
  • Knowledge, Skills, and Abilities

  • Strong understanding of CRF, CDISC, Clinical Data Management, GCP (Good Clinical Practice), and ICH Regulations.
  • Proficiency in Veeva Vault and other data management platforms.
  • Ability to effectively apply knowledge and skills in a highly organized manner while adhering to regulatory guidelines, SOPs, and client expectations.
  • Proficient in interactive computer programs and clinical data management tools.
  • Excellent written and verbal communication skills, with strong command of English grammar.
  • Strong organizational, analytical, and problem-solving skills with exceptional attention to detail.
  • Ability to work both independently and collaboratively in a team environment.
  • Demonstrated ability to maintain strict confidentiality with clinical and client proprietary data.
  • Proven capability to act as a study or departmental expert for data management processes.
  • Skilled in project resourcing, timeline planning, and ensuring adherence to project schedules.
  • #J-18808-Ljbffr

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