Study Manager, Global Study Operations

Position: Study Manager, Global Study Operations

Location: Remote

Contract Duration: 6-month contract with high likelihood of extension up to 2 years

Start Date: ASAP

Key Responsibilities:

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

Qualifications:

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.

Medasource is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

Benefits & Perks:

Medasource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.

Pay Disclaimer:

The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.

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