Gcp Compliance Manager

vor 5 Monaten

Basel, Schweiz Novartis Vollzeit

394905BR

**GCP Compliance Manager (Program & Study)**:
Switzerland

**About the role**

**Location: Basel, Switzerland (Onsite/Hybrid)**
**#LI-Onsite #LI-Hybrid**

We are seeking a GCP Compliance Manager (Program & Study) to be accountable for the compliance oversight and control of regulated Global Clinical Operations (GCO) activities focusing on program/trial level delivery as per program(s)/trial(s) assignment. This role contributes to all compliance activities supporting the three pillars of GCP Compliance, issue management, audits & inspections as per program/trials’ selection and GCO self-strategy delivery.
This role will work directly with the Process, Training & GCP Compliance, Global Clinical Operations team and reports to the GCP Compliance Head (Program & Study).
**Key Responsibilities**:

- Accountable for the compliance oversight and control of regulated GCO activities focusing on program/trial level delivery as per program(s)/trial(s) assignment.
- Acting as single point of contact for Clinical Trial Teams for GCP Compliance.
- As per focus area and assignment, management and day-to-day support provided program/trial level quality issues, deviations and quality events management.
- Coordination and support to Clinical Trial Teams for audits and inspections based on program/trial/country’ selection and scope.
- Delivery of the GCO self-assessment strategy related checks and controls.
- Supporting cross-functions risk assessments if programs or trials identified and contribute to the monitoring of relevant indicators/metrics/thresholds.
- Contributing to the execution of the GCO GCP Compliance strategy under the leadership of the GCP Compliance Head (Program & Study).
- Driving the compliance oversight and control of regulated GCO activities focusing on program/trial level delivery as per program(s)/trial(s) assignment, working closely with the Clinical Trial Teams and the relevant functions across GCO, involving and collaborating as required with GDD and the wider organization, such as Quality Assurance.

**Commitment to Diversity & Inclusion**:

- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Role Requirements**

**Essential Requirements**:

- Advanced degree in science, engineering or relevant field.
- 8+ years industry experience specifically in clinical operations and trial management with a strong understanding of clinical research international standards and regulatory requirements from Health Authorities. Audits and inspections experience highly desirable.
- Organizational and analytical skills associated with a proficiency in quality management and continuous improvement.
- Critical thinking ability and risk management and risk-based knowledge and approach.
- Ability in partnering with a proactive and solution-oriented approach.
- Strong skills to facilitate/optimize contribution of team members as individuals and members of a cohesive team.
- Ability to work effectively in a matrix cross-functional environment.

**Commitment to Diversity & Inclusion**: Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
**Commitment to Diversity & Inclusion**: Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.

**Division**

Development

**Business Unit**

GCO GDD

**Work Location**

Basel

**Company/Legal Entity**

Novartis Pharma AG

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No

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