Sr. Clinical Research Manager

Employment Type

: Full-Time

Industry

: Miscellaneous



Job Purpose

Provide clinical study management and implementation for Clinical and Translational Pharmacology clinical studies at Theravance Biopharma including but not limited to first in human, proof of mechanism and clinical pharmacology labeling studies in accordance with Good Clinical Practice (GCP) and Theravance Biopharma Standard Operating Procedures. 

Duties and Responsibilities

This position will provide leadership and support for clinical phase 1 and clinical pharmacology studies across therapeutic areas including but not limited to respiratory, gastrointestinal, cardiovascular, ocular, central nervous system, and inflammatory diseases. 

The duties and responsibilities include but are not limited to the following: 

  • providing operational input and oversight in designing, planning, initiating and completing clinical pharmacology studies across a program level. 
  • write or oversee the writing of key clinical documents including but not limited to study protocols, informed consent forms, and clinical study reports. 
  • collaborate with various in-house functional groups as needed to develop key study plans including but not limited to pharmacy manuals, biological sample collection plans, monitoring plans, data management plans, statistical analysis plan and other study plans as needed for a given project
  • effectively lead the Clinical Operation Study Team(s) including in-house team members and those from Contract Research Organizations (CROs), vendors and other suppliers as needed.
  • manage the progress and conduct of clinical studies to ensure adherence to study protocols, regulatory expectations, internal operating procedures, and intended timelines and budget.
  • disseminate clinical study progress reports to appropriate functional groups, and attend project team meetings as needed
  • duties also will include participating in or leading cross functional initiatives aimed at developing or improving clinical operation processes and standard operating procedures, particularly as it applies to phase 1 and clinical pharmacology studies. 
  • Qualifications

    Position requires a minimum of a Bachelor of Science degree and at least 3 years of clinical study management experience, including 2 to 3 years of experience working on phase 1 or clinical pharmacology studies within a pharmaceutical or biotech environment or relevant CRO experience.

    High level of understanding of the clinical study implementation process.

    Strong understanding of CFR and ICH guidelines.
    Excellent oral and written communication skills
    Exceptional interpersonal and leadership skills with proven ability to effectively work within a multidisciplinary team.

    Willingness to travel up to 30%, as necessary, consistent with study or functional needs.

    Direct Reports

    This position does not have any direct reports at the present time but it is expected that this position will have the capabilities to take on supervisory responsibilities for in-house and or consultant staff.

    Physical Requirements

    None.

    Working Conditions

    Regular working condition in office area. Full time schedule is expected.


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