Clinical Project Manager leading the planning and execution of Global Drug Development studies for Novartis in China. Collaborating with various teams to ensure compliance and timely delivery of studies.
MS
Hybrid Senior Study Manager, Clinical Research Operations – Ophthalmology
Posted last week
About the role
- Senior Study Manager leading operational planning and execution of clinical trials for pharmaceutical company. Collaborating across global, cross-functional teams in ophthalmology trials.
Responsibilities
- Responsible for the operational planning, feasibility, and execution of a clinical trial
- May serve as the clinical trial team lead
- May lead team in key study planning, development, and execution elements (e.g., data management deliverables, trial level plans/timelines, country/site selection, site materials, system updates, investigator meeting planning, communication plans, preparation of status update reports, study close out activities)
- Leads team for timeline management, risk identification and mitigation, issue resolution
- May facilitate and collaborate with key internal/external stakeholders (e.g., study team, country teams, vendors, committees) in support of clinical study objectives
- Accountable for managing any study specific partners and/or vendors.
Requirements
- Bachelor's Degree +5 years of pharmaceutical, clinical drug development, project management, and/or medical field experience
- OR Master's Degree +3 year of pharmaceutical, clinical drug development, project management, and/or medical field experience
- OR PhD/PharmD Degree in life sciences, preferred
- Ophthalmology experience required
- Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH)
- Ability to manage multiple competing priorities with good planning, time management and prioritization skills
- Solid understanding of the principles of project planning & project management
- Good 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 and leadership driving toward study goals
- Problem solving, prioritization, conflict resolution, and critical thinking skills
- Applying leadership skills to processes, leading meetings, and influencing peers in a matrix environment
- Build team capabilities through proactive coaching.
- Strong communication, technical writing, and presentation skills.
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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