8547 Global Study Operations Manager

Responsibilities include but are not limited to:
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.

Other responsibilities Include:
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:

Core:
Decision Making and Problem Solving.
Influence and Organizational Awareness.
Agility and Proactivity.
Leadership.
Communication and Collaboration.

Technical:
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).

Education:
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.

The hiring range for this position is $56 to $66 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate’s geographic region, job-related knowledge, skills, and experience amongst other factors.

Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.