Clinical Operations Manager -- Remote | WFH - Get It Recruit - Finance
Rahway, NJ 07065
About the Job
Are you ready to make a significant impact in the world of healthcare innovation? Join our dynamic team as a Remote Clinical Operations Manager - Finance and play a vital role in ensuring the safety and efficacy of groundbreaking medicines.
About the Role:
As a Remote Clinical Operations Manager, you'll be responsible for overseeing performance and compliance for assigned protocols within a country, ensuring adherence to industry standards, regulations, and company policies. Your work will be pivotal in driving forward the success of clinical trials and pharmacovigilance efforts, ultimately contributing to the development of safe and effective medicines.
Key Responsibilities:
Take ownership of country and site budgets, leading the negotiation and completion of Clinical Trial Research Agreements (CTRA).
Oversee and track clinical research-related payments, ensuring financial compliance and accurate reconciliation.
Execute and manage clinical trial country submissions and approvals for assigned protocols, liaising with regulatory authorities and IRB/IEC.
Develop local language materials, including translations and Informed Consents, and collaborate closely with internal and external stakeholders to meet country-specific milestones.
Provide support and oversight to local vendors, coordinating processes related to clinical and ancillary supplies management, import/export requirements, and insurance processes.
Act as a subject matter expert, contributing to the development of local SOPs, sharing best practices, and providing training and mentorship as needed.
Required Skills and Qualifications:
Bachelor's Degree in Business, Finance, Administration, Life Science, or equivalent experience.
5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business.
Strong understanding of budget and contract negotiations, local regulatory environments, and submission/approval processes.
Excellent verbal and written communication skills in both local language and English, with the ability to influence and train/mentor others effectively.
Proactive problem-solving abilities, with a high sense of accountability and urgency.
Ability to work independently and collaboratively in a remote/virtual environment.
Employment Type: Full-Time
Salary: $ 111,000.00 Per Year
About the Role:
As a Remote Clinical Operations Manager, you'll be responsible for overseeing performance and compliance for assigned protocols within a country, ensuring adherence to industry standards, regulations, and company policies. Your work will be pivotal in driving forward the success of clinical trials and pharmacovigilance efforts, ultimately contributing to the development of safe and effective medicines.
Key Responsibilities:
Take ownership of country and site budgets, leading the negotiation and completion of Clinical Trial Research Agreements (CTRA).
Oversee and track clinical research-related payments, ensuring financial compliance and accurate reconciliation.
Execute and manage clinical trial country submissions and approvals for assigned protocols, liaising with regulatory authorities and IRB/IEC.
Develop local language materials, including translations and Informed Consents, and collaborate closely with internal and external stakeholders to meet country-specific milestones.
Provide support and oversight to local vendors, coordinating processes related to clinical and ancillary supplies management, import/export requirements, and insurance processes.
Act as a subject matter expert, contributing to the development of local SOPs, sharing best practices, and providing training and mentorship as needed.
Required Skills and Qualifications:
Bachelor's Degree in Business, Finance, Administration, Life Science, or equivalent experience.
5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business.
Strong understanding of budget and contract negotiations, local regulatory environments, and submission/approval processes.
Excellent verbal and written communication skills in both local language and English, with the ability to influence and train/mentor others effectively.
Proactive problem-solving abilities, with a high sense of accountability and urgency.
Ability to work independently and collaboratively in a remote/virtual environment.
Employment Type: Full-Time
Salary: $ 111,000.00 Per Year
Source : Get It Recruit - Finance