Quality & Compliance Manager - Clinical Trials

Quality & Compliance Manager - Clinical Trials

Remote working with quarterly meetings in Brentford

Pay rate up to £550 per day via Umbrella inside IR35

Initial contract until December 2022

The key purpose of this role is to ensure the safety of all GSK Clinical Trial participants and patients administered GSK products, by ensuring the successful collection, assessment and reporting of safety data (adverse events).

This role ensures that case processing activities align with GSK standards for processing HSI and that regulatory timelines are achieved. This is done by ensuring Quality of CMG data and Compliance with Regulatory Requirements and company procedures.

The job holder ensures relevant Quality and Compliance-related oversight to the Case Management Group (CMG) Directors and drives the Quality and Compliance processes.

ACCOUNTIBILIITES / RESPONSIBILITIES:

(deliverables, scope, complexity, impact on strategy, policy, people relationships)

Core Quality Accountabilities

·      Works across a complex matrix environment to drive high-quality delivery of case management activities that comply with internal standards and external regulatory requirements

·      Generates new ideas and proposals for global implementation; contributes to advancement of CMG methodology and processes

·      Monitors Key Performance Indicators (KPIs) ensuring compliance and quality thresholds are met and any metrics indicating missed KPIs are addressed.

·      Input into Root Cause Analysis (RCA) and corrective/preventive action (CAPA) formation/effectiveness checks

·      Independent quality review of cases processed by vendor

·      Ensures appropriate reporting activities are complete, as per Regulatory requirements

·      Ensures that changes to Regulations are assessed for impact and any necessary changes are implemented, also providing awareness to QPPV Office.

·      Support risk assessment and management of risk registers

·      Supports Inspections/Audits (led by PVQA of Central/LOC/Vendor processes)/ LP Audits/ Regulatory Inspections (Central and LOC)/ Notified Body Audits

·      Ensures appropriate management monitoring activities are complete

·      Where problems or issues are identified, ensures appropriate escalation and resolution

·      Demonstrates GSK values during interactions

Management Quality and Compliance Accountabilities

·      Manages a team of up to 10 scientific staff responsible for supporting quality/compliance

·      Manages team to ensure appropriate prioritisation and time management, in line with business needs

·      Builds external relationships with senior leaders

·      Ensures relevant Quality and Compliance-related oversight to the Case Management Group (CMG) Directors

·      Resolves issues and concerns within the Quality and Compliance team and escalates to Quality and Compliance Director, where resolution is not possible or there is impact across CMG

·      Ensures that all Quality and Compliance activities are appropriately resourced and escalates any resourcing issues

·      Provides workload forecasts to CMG Directors and works with Quality and Compliance Director to strategically plan, in line with business goals

·      Develops the team, identifying training requirements and working with training team to establish a training plan for individuals

SKILLS AND EXPERIENCE

Essential Core Quality and Compliance skills

·      Degree in life sciences or medically related field or previous experience equating to educational requirements. 

·      Knowledge of Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP), clinical safety documentation, reporting of adverse events from clinical trials, local regulatory requirements, and pharmacovigilance methodology; general understanding of worldwide regulatory requirements

·      Working knowledge of principles of data collection, manipulation and retrieval and experience summarizing data

·      PV Quality and Compliance experience preferred

·      In-depth understanding of medical and drug terminology

·      Proven experience of Prioritisation and time management

·      Strong communication skills

Desirable Quality and Compliance skills and Experience

·      Health care professional (e.g. pharmacist or nurse) preferred.

·      In-depth knowledge of GSK safety database preferred

·      Knowledge of GSK products

Global CMG Quality and Compliance Manager

·      Proven experience developing and delivering high-quality training

·      Proven experience in line management

·      Experience of using escalation mechanisms

COMPETENCIES

Core Quality and Compliance Competencies

·      Working knowledge of principles of data collection, manipulation and retrieval

·      Working knowledge of local regulations, relevant GSK SOPs and SMG guidance documents

·      Demonstrates technical understanding of safety processes including regulatory interpretation, SOP/GUIs, Systems/data base conventions

·      Prepare and present data/information within and outside of SMG

·      Demonstrates excellent oral and written communication skills across cultural and language boundaries

·      Demonstrates technical expertise in clinical trial safety processes, including regulatory interpretation, SOPs/guidances, and systems/database conventions

·      Possesses comprehensive operational knowledge and understanding of the drug development process and drug approval process in major countries

·      Attention to detail, but demonstrates pragmatism where appropriate or high degree of accuracy and attention to detail

·      Possesses solid/excellent technical writing skills

·      Possesses solid/excellent computer skills and computer literacy (e-mail, word processing, PowerPoint, prefer experience with relational databases, i.e. ORACLE)

Global CMG Quality and Compliance Manager

·      Demonstrates soft skills required to line manage individuals

·      Able to coordinate challenging conversations to resolve issues in a professional manner, demonstrating GSK behaviours and recognise when escalation is required

• Contact us
• Terms of Service

Elevate Platform LTD. Copyright © 2022 - All Rights Reserved.