Global Principal Clinical Scientist

King of Prussia, PA

Perm Salary

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OVERVIEW

The Global Principle Clinical Scientist role is a multifunctional, clinical project position in the therapeutic area. The position holder works closely with other Clinical Scientists on the team, Global Clinical Program Directors and Global Therapeutic Area Head performing delegated tasks in support of the clinical development program as dictated by therapeutic area/ project needs.

RESPONSIBILITIES

  • The position holder contributes to the scientific development of individual clinical studies in alignment with the approved clinical development plan 
  • Includes authorship/ review of some clinical documents (protocols, CRFs, ICFs, CSRs, etc.) to ensure that the scientific content/ rigor is consistent and of the highest quality across the clinical development program
  • Contributes to the clinical oversight and medical guidance in collaboration with the team Principal/Senior Clinical Scientist, and (Senior) Global Clinical Program Directors during the conduct of the study
  • Reviews clinical data with some assistance and contributes to the development of clinical presentations and integration of analyses into clinical documents
  • Liaisons with internal stakeholders (clinical operations, data management, statistics, safety, commercial, and regulatory affairs) and investigators
  • Assists with the planning and monitoring of the timelines, resources and budget for the scientific part of the clinical program (Medical Writing, Ad Boards etc.)
  • Manages the processes required to support external study review committees; e.g. data
  • monitoring committees, steering committees
  • Contributes to multidisciplinary task forces to support continuous improvement (i.e. quality circles, SOP harmonization)

EXPERIENCE

  • Strong knowledge of clinical research procedures, GCP and SOPs and understanding of drug development process
  • Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines
  • Involvement in cross-functional, multicultural and international clinical trial teams preferably with experience in cardiovascular mega trials
  • Experience in medical/regulatory writing preferable
  • Excellent communication skills
  • Ability to work successfully in a matrix organization
  • Ability to manage  external relationships with Key Opinion Leaders
  • Fluent in English, oral and written

EDUCATION

  • Bachelor degree or equivalent education/degree in life science/healthcare required if accompanied with ≥ 3 years experience in clinical research

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology. 
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines. 
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure. 
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.   
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.  

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

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