Clinical Sciences Manager
hace 9 horas
**Summary**:
Contributes, with appropriate oversight, to all aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May lead specific aspects of global clinical trial process. Contributes to operational excellence through process improvement and knowledge sharing.
- Responsible and accountable for execution of assigned clinical research tasks related to, Investigator Initiated Trials (IITs), Expanded Access Programs (EAPs, MAPs), Research Collaborations (RCs), and non-Interventional studies (NIs)
**About the Role**:
**Key responsibilities**:
- Operational clinical activities like process improvement or other line function initiatives.
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
- Preparation of trial related documentation, TMF maintenance, ensuring key processes and documents are maintained/updated on time (e.g. TPSR, ICF Clinical Review, TMF).
- Supports the management and tracking of trial budgets including payments working closely with the appropriate partners
**Main Requirements**:
- Bachelor's degree in a science related field or a Registered Nursing certification or equivalent certification/licensure from an appropriately accredited institution.
- +6 years' experience with significant clinical research or research monitoring experience (comparable to 6 years) that provides the required knowledge, skills and abilities and experience mentoring or training others.
- Evaluate medical research data and proficient knowledge of medical terminology.
- Effective oral and written communication skills, with the ability to communicate effectively with medical personnel.
- Strong customer focus.
- Fluent in English.
Division
US
Business Unit
Marketing
Location
Mexico
Site
INSURGENTES
Company / Legal Entity
MX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No
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