Work Location: Billerica, Massachusetts Shift: No Department: HC-RD-DTN N&I Clinical Trial Management Recruiter: Rena Ann Peterson
This information is for internals only. Please do not share outside of the organization.
Your role
Manages multiple studies, projects, and work streams with
high complexity, risk, impact and reach, typically Ph III and registrational/sourcing models.
Demonstrates skills in successfully leading large-sized global project teams in a matrix organization and directs, influences and motivate stakeholders from closely related areas and beyond, creating a positive working climate.
Leads the development of the clinical trial strategy while accountable for successful project execution and delivery of clinical operational budget, timelines and quality standards agreed upon by Governance Committees.
As a core member of the Clinical Operations Team and leader of the Clinical Trial Team, aligns clinical trial team with organizational goals, Clinical Operations Team, and/or Global Program Strategy Team.
Filters, prioritizes, analyzes and validates complex and dynamic information from a diverse range of external and internal sources to respond to operational and organizational challenges in a holistic manner to mitigate risks.
Exhibits Subject Matter Expert level understanding of multiple functions and functional processes. Familiar with and considers overall company strategy.
Acts as a senior advisor and mentor within the team and beyond and serves as best practice resource within own discipline or as technical functional teams or projects.
Ensure all study management activities will be completed in accordance with SOPs/WI, local regulatory guidance including ICH-GCP; audit leadership- interviewee & responses.
Contribute to non-study -related initiatives in addition to study assignments. Provide reports to senior management, including updates and timelines independently.
Demonstrates creativity and innovation to support projects from a strategic perspective, able to predict the result of action in advance and achieve goals.
Who you are
At least 10 or more years in clinical research in a CRO or Pharmaceutical/Biotechnology Industry environment with at least 7 years of in-depth experience in clinical trial management including managerial responsibility. Advanced degree desirable (MPH, MS, MA, MBA, PharmD); PM cPMP) desirable.
Proven experience in all aspects of clinical study planning and startup (including budget and resource planning) and in executing study activities, from startup through final study report.
Experience in multiple Therapeutic Areas (oncology and immunology preferred)
Requires substantial to extensive professional experience in relevant disciplines and substantial project management experience. Required and experience in own discipline and beyond which may also require good market and competitor knowledge.
Strong leadership competencies and influencing skills.
Proven team dynamic knowledge and skills and ability to foster partnerships across projects and multidisciplinary teams.
Growing expertise in drug development, including some knowledge of interfaces and interdependencies of clinical development with other nonclinical & pharmaceutical development, regulatory, commercial/marketing)
Location: Billerica MA or EST if remote
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