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Clinical Sciences Manager
hace 2 semanas
**Summary**:
Responsible and accountable for execution of assigned clinical research tasks related to IITs, MAPs, RCs, and NIS/LIS
**About the Role**:
LI-Hybrid
Location: Mexico City
**Key Responsibilities**
- Accountable for the accuracy and timeliness of trial information in all trial databases and tracking systems.
- Facilitates MRC and SRC review of concepts
- Timely processing of MAP requests, maintenance of request and closure
- Interfaces with the disease area(s), global and US clinical team members, regulatory affairs, drug supply, data management, finance and other relevant functional areas
- Preparation of trial related documentation, TMF maintenance: project files including ethics committee approvals; curricula vitae of investigators and study personnel; clinical investigators brochure; protocols; case report forms instructions; consent documents; clinical trial material shipping orders; start-up meeting attendance documentation; letters of agreement; lab reference ranges; all investigator and site correspondence; and schedules of payment.
- Ensures key processes and documents are maintained/updated on time (e.g. TPSR, ICF Clinical Review, TMF)
- Ensures TPSR & Pubs Review
- Initiation of IND x-ref letter and IN & IB distribution
- Establishes charters for and support management of SC and EO
- Conducts Pre-RC alignment and Ensure EPRM and TPIAT completion for RCs (internal and external interface management)
- Responsible for the initial and subsequent drug supply across trials within a therapeutic area in collaboration with the Local Clinical Supply Manager.
- Contributes to the preparation and review of clinical program documents (PowerPoint presentations, IND annual report, regulatory documents, clinical study reports, (CSR) and submissions) and other study related documents assuring quality and consistency.
- Supports the management and tracking of trial budgets including payments working closely with the appropriate partners
- Study close out execution, including financial reconciliation, creating closure letters
- Prepares for and supports quarterly review meetings with TA teams
- Understands and complies with company SOPs and GCPs; contributes to continuous improvement in SOPs and local Working Practices.
- Any other clinical activities as assigned
**Essential Requirements**
Bachelor's degree in a science related field or a Registered Nursing certification or equivalent certification/licensure from an appropriately accredited institution.
**Languages**
- Strong Englisth proficiency
**Experience required**:
- 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.
- In some cases, an equivalent combination of education, professional training, and experience that provides the required Knowledge, Skills and Abilities may be considered.
**Technical Knowledge/Competencies**:
- Ability to 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.
- Excellent interpersonal skills.
- Strong attention to detail.
- Ability to utilize problem-solving techniques applicable to constantly changing environment.
- Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software.
- Good English language and grammar skills.
- Effective presentation skills.
- Conducts above activities with mínimal oversight, ability to work independently. Mid to High-level competency for above activities.
- Ability to mentor and train other clinical associates in a positive and effective manner.
- Effective organizational and time management skills.
- Proven flexibility and adaptability.
- Excellent team player with team building skills.
- Ability to work independently as required.
**Commitment to Inclusion**
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Division
Finance
Business Unit
Universal Hierarchy Node
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
**Ajustes de accesibilidad**:
