Senior Clinical Research Manager
4 weeks ago
Responsibilities;
- Main Point of Contact (POC) for assigned protocols and link between Country Operations and Clinical Trial Team (CTT).
- May support TA-Head / CRD with oversight of Therapeutic Area program(s) and strategy alignment as needed.
- 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.
- Performs Quality control visits as required.
- 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 different local country roles ensuring a strong collaboration (including the CTCs, CRAs and COMs).
- Responsible for end-to-end performance of assigned protocols in Middle East and Egypt
CORE Competency Expectations:
- 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
- Proficiency in written and spoken English and local language. The incumbent must be competent and effective in written and verbal communication.
- Strong scientific and clinical research knowledge is required. Including extensive knowledge of regional and/or country clinical trial landscape.
Behavioral Competency Expectations:
- 10+ years of experience in clinical research with demonstrated success and increasing responsibilities of which 5+ years consisted of leading projects.
Educational Requirements:
- Bachelor degree in Science (or comparable)
- Preferred: Advanced degree, (e.g., Master degree, MD, PhD)
**Search Firm Representatives Please Read Carefully**
**Employee Status**:
Regular
**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
Not Applicable
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R288266
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