Associate Director, Study Manager - Atherosclerosis and Metabolism

This position participates in the strategy and leads the operational planning and execution of one or more clinical trials. In this position, you will have the opportunity to demonstrate your advanced leadership and technical skills as part of a global, cross-functional team. You will build and coach your team in the development of project management, communication, and collaboration skills in support of our clinical trials.

• Responsible for the operational planning, feasibility, execution and conduct of clinical trial(s).
• Serves as the Clinical Trial Team (CTT) lead
• Leads and directs teams in key study planning, development, and execution elements (e.g. operational reviews, issue escalation/mitigations, presentations agement meetings, program level cross functional meetings and governance).
• Responsible for facilitating and collaborating with key internal/external stakeholders (study team, subsidiary country teams, vendors, committees, etc.) in support of clinical trial objectives.
• Liaises with partners, vendors, and vendor management team.
• Review and provide clinical operations input into relevant clinical documents such as the protocol and other documents as appropriate.
• May serve as a subject matter expert and/or participate on process improvement teams.
• Builds talent and capabilities of junior team members through proactive coaching, mentoring and development opportunities.
• May include management of direct/indirect reports including assignment of resources, professional development, and performance management.

• Strong knowledge of clinical research regulatory requirements e.g., Good Clinical Practice (GCP) and International Council for Harmonisation (ICH)
• Proven ability to manage competing priorities and effectively delegate and assign activities to meet the business needs
• Ability to develop short and mid-range project plans that are realistic and effective at meeting goals
• Strong analytical skills to drive operational milestones
• Influence opinions and decisions of internal and external customers/vendors, across functional areas, and within the division
• Interact with key stakeholders across department, division, and company. Role requires a proactive approach, strategic thinking and leadership driving toward study goals.
• Demonstrated leadership skills in programs & processes, leading meetings and influencing peers and direct/indirect reports in a matrix environment.
• Problem solving, prioritization, conflict resolution, and critical thinking skills
• Strong communication, writing, and presentation skills
• Proficient knowledge in Microsoft office or similar (Excel, PowerPoint, Word, Outlook, etc.)

• Bachelor's Degree and 9+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience
• -OR
  - Master's Degree and 6+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience
• -OR
  - PhD/PharmD Degree and 2+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience
• Degree in life sciences, preferred

Adaptability, Analytical Problem Solving, Clinical Data Management, Clinical Study Management, Collaboration, Detail-Oriented, Ethical Standards, Good Clinical Practice (GCP), Stakeholder Alignment, Strategic Thinking

Process Improvements, Program Management, Project Management

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

$ - $

Regular

No relocation

No

10%

Not Applicable

1st - Day