What are the responsibilities and job description for the Clinical Trial Manager position at Makonis?
Client: A leading Pharmaceutical Manufacturing (Product) Brand
Work Location: Jersey City, NJ
KEY ROLES AND RESPONSIBILITIES:
- Manage contracts and study budget
- Development of RFPs, selection of CROs/vendors
- Manage and lead cross-functional study teams in CRO, including vendors
- Development of study documents such as protocol, CSR, and publication materials
- Review of CRF and other operational materials, if required
- Provide accurate and up-to-date study information and study progression to manager or leadership and other stakeholders
- Communicate with investigators and investigative site staff
WORK EXPERIENCE:
- Minimum 3-5 years of experience in late phase trials, IIT/Registry or Phase 4 study or similar role
- managing clinical trials, particularly in an IIT setting.
- Full cycle experience is a plus
- Strong clinical study management skills (including project and financial management)
- CRO/vendor management experience, including experience in audits and inspections
- Excellent communication skills, both written and verbal.
- Strong problem-solving and decision-making abilities.
- Ability to work cross-functionally with various stakeholders.
- Ability to work virtually
QUALIFICATIONS:
- Familiarity with medical terminologies, medical information reporting, and regulatory requirements.
- Managed and maintained medical data and systems.
- Excellent written and verbal communication skills
- Understanding of issues in medical information and medical review
EDUCATION:
- Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related field. Master’s or advanced degree preferred.
CORE COMPETENCIES:
- Knowledge – medical terminology and regulatory requirements.
- Communication - clear, concise, and ability to motivate; ability to articulate medical information of the Company’s products.
- Collaboration - ability to communicate across functions and at all levels in the organization.
- Compliance – understands industry regulations to maintain compliance.
If your profile matches this requirement, please do share a copy of your resume to gunjan.t@makonissoft.com at an earliest.
Salary : $120,000 - $140,000
