Clinical Research Manager - Ophthalmology
New
Source API remote eligibility restrictions: United StatesFull-TimeManager
Salary142,400 - 224,100 USD per year
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Job Details
- Languages
- Proficiency in written and spoken English and local language.
- Experience
- 5 years of experience in clinical research.
- Required Skills
- Project ManagementOrganizational skills
Requirements
- 5 years of experience in clinical research.
- Strong Ophthalmology experience required, with retinal disease experience strongly preferred.
- Bachelor's degree in science (or comparable)
- Knowledge in Project Management and site management.
- Strong organizational skills with demonstrated success required.
- Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight and supervision of the TA Head or CRD.
- Requires strong understanding of local regulatory environment.
- Strong scientific and clinical research knowledge is required.
- Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
- Experience functioning as a key link between Country Operations and Clinical Trial Teams.
- Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions.
- Ability and skills to manage resource allocation, processes (and controls), productivity, quality and project delivery.
- Proficiency in written and spoken English and local language.
- The position requires proven strong project management skills and/or project management certification or relevant training program/close mentoring.
- Strong leadership skills that enable and drive alignment with the goals, purpose and mission of our Company's Research Labs, Global Clinical Development (GCD) and GCTO.
- Ability to identify problems, conflicts and opportunities early and lead, analyze and prepare mitigation plans and drive conflict resolution is critical.
Responsibilities
- Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).
- Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
- Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
- Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
- Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the CTC, CRAs and COM).
- Responsible for creating and executing a local risk management plan for assigned studies.
- Ensures compliance with CTMS, eTMF and other key systems in assigned studies.
- Identifies and shares best practices across clinical trials, countries, clusters.
- Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.
- Serves local business needs as applicable in his/her country (if delegated can sign contracts and manage budgets).
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