What are the responsibilities and job description for the Study Manager, Global Study Operations position at TALENT Software Services?
Responsibilities include but are not limited to:
Within the role, the candidate is expected to show and have proficiency and experience in the following competencies:
- Overall study execution oversight
- Provide leadership, guidance, and direction to GSO staff assigned to studies
- Lead cross-functional Study Execution Team (SET) meetings
- Collaborate with cross-functional study members to drive and execute on study deliverables, documents, and plans
- Proactively identify, manage, and communicate cross-functional study issues, risks, and mitigations in a timely manner
- Provide regular study quality and progress updates to key stakeholders as needed
- Monitor and act upon study metrics; review trend-identification and analysis and provide targeted follow-up where appropriate
- Collaborate with other Study Managers to ensure consistency and maintenance of the various study plans within a program
- Collaborate with People and Process Managers of the Study Specialist staff to support team member productivity and career growth
- Contribute to the Study protocol and Informed Consent Form (ICF) development
- Management of GSO Study Timelines
- Management of CRO and Vendors
- Management of Study Lifecycle (start-up, enrollment, maintenance, and close-out)
- Oversight of Drug / Investigational Product (IP) process
- Management of Study Budget
- Oversight of Feasibility, Recruitment, and Enrollment
- Oversight of Study Outcome and Data Deliverables
- Lead or participate in program or study-specific projects that have a wider impact
- Collaborate with study managers/cross-functional team members to implement department process change and efficiencies
Within the role, the candidate is expected to show and have proficiency and experience in the following competencies:
- Decision Making and Problem Solving
- Influence and Organizational Awareness
- Agility and Proactivity
- Leadership
- Communication and Collaboration
- Data Analysis and Interpretation
- Study Management and Execution
- Compliance and Quality
- Drug Development and Study Design
- Product and Therapeutic Area Knowledge
- Knowledge of managing all phases of clinical trials (Early Clinical Development/Ph 1 through Post Approval studies)
- BA/BS/BSC- 5 years’ work experience in life sciences or medically related field, including at least 3 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical, or CRO setting.
