Editor: 

The Breast International Group (BIG) is a non-profit research organization that represents the largest global network of academic groups dedicated to breast research. 30+ clinical trials are run or under development under the BIG umbrella at any one time. BIG is looking for a:

QUALITY MANAGER & PROJECT MANAGEMENT LEADER

Function: As Quality Manager, Responsible for the Quality Management System and Operational Standards of the association (30%). As Project Management Leader, provide senior-level operational leadership for the BIG HQ project management (PM) team (70%).

Primary Responsibilities:

Quality Manager

  • Manage the development and implementation of the Quality Management System
  • Participate in the analysis of the organization’s processes and identify missing procedures
  • Write SOPs, Policies, templates, Working Instructions, Guidelines and other related documents that reflect the organization’s working procedures and comply with ICH/GCP requirements (when applicable)
  • Coordinate the review of QMS documents
  • Review and update existing QMS documents as needed
  • Serve as designated in-house expert for ICH-GCP issues
  • Keep inventory of current procedures and procedures to be developed
  • Coordinate the preparation of audits and inspections
  • Lead in the preparation and implementation of CAPA plans following an audit or inspections
  • Support compliance monitoring and continuous improvement initiatives
  • Manage non-conformities and quality incidents in consultation with R&D Director, Research Operations Director and/or CEO
  • Advise the R&D Director, Research Operations Director and CEO on quality issues in general
  • Liaise with external QA expert as determined in consultation with CEO
  • Review study documents (including but not limited to protocol, Main Study Agreement(s), Scope of Work, Participant Information Sheet and Informed Consent Form, ,…) for senior input and standardization
  • Work with HR Team on the development of training materials, as needed
  • Work with the training manager and the department directors on the development of the training matrix and some training materials, as needed.

Project Management Leader

  • Provide operational leadership for PM team working on clinical trials
    • Work closely with the PM during the set-up of a project, to ensure compliance with BIG principles and processes
    • Review key study documents prepared by the PM, such as charters and policies
    • Review study budgets and contracts
    • Prioritize PM tasks, set timelines and monitor progress
    • Help resolve specific trial-related or other operational project issues
    • Provide close guidance for « sensitive » issues, e.g., identifying signs of problems, determining need for escalation
    • Provide guidance for PM—coordinated meeting preparation and follow-up
    • Participate in internal Team Meetings
    • Serve as a senior level operational contact for multiple study partners, including academic collaborative research groups, the bio-pharmaceutical industry, and a variety of vendors,  participating in meetings, and supporting PMs in  preparing, and following- up as necessary
  • Lead specific studies / projects and guide the PMs’ tasks related to those studies
  • Serve as line manager and direct supervisor for individual PMs
    • Train / coach PMs on BIG guidelines, policies and SOPs
    • Participate in professional development discussions, setting objectives and training plans with PMs
  • Work closely with other PM Leaders, to identify and resolve common PM and trial operational issues,to be discussed during recurring PM meetings
  • Identify areas of improvement in BIG HQ operations and contribute to its continuous optimization (e.g., development of new procedures, tools, etc)
  • Participate in initiatives aimed at harmonizing or improving the efficiency of interactions between BIG HQ and BIG member groups
  • Develop training modules for PMs on a need basis, in collaboration with the PMLs and ROD
  • Support Research Operations Director as needed

Qualifications sought:

  • Academic degree, preferably in a (para)medical discipline
  • Experience as a Quality Manager with a good knowledge of GCP and methodologies, regulations and procedures related to clinical trials
  • Experience in the set-up and management of all operational aspects of clinical trials (in academia, industry, or CRO)
  • Experience in oncology clinical trials is a plus
  • Previous experience in managing budgets and contracts is a plus.
  • Possess strong analytical skills and highly organized project management abilities, sense of diplomacy, and  keeping an eye on both detail, while maintaining a broad overview
  • Leadership skills
    • People Management experience
    • Communicate effectively in multicultural teams within BIG headquarters and the BIG network, and across organisational boundaries, respecting differences between people from a variety of linguistic and cultural backgrounds
    • Motivate and guide the team to learn, interpret and apply a variety of complex policies and procedures with minimal guidance
    • Inspire team work
    • Maintain a high level of poise and professionalism while coordinating a diverse variety of daily and special project deadlines simultaneously
  • Native or native-like written and spoken English; French, Dutch or other languages are a plus
  • A high level of integrity and sense of responsibility and professionalism

What we offer:

  • The opportunity to contribute to innovative, practice-changing cancer research
  • A stimulating international environment
  • Full-time employment and unlimited duration contract
  • A competitive salary and benefits package:
    • Annual salary on 13.92 months
    • Possibility to telework and have flexible working hours
    • 26 days of holiday per year, plus one additional every 5 years of seniority
    • Employee group insurance (employer contribution 4% & employee contribution 2% on annual gross salary)
    • Hospitalization insurance at employer charge only for the employee
    • Intervention public / private transport
    • Luncheon vouchers - Face value EUR 8,00 - employee contribution: EUR 1,09 per working day
    • Eco vouchers - annual net value of 250 EUR/Year for full year full time from July to June
    • Mobile phone according to internal policy (Benefit in kind will apply if private use as per the legislation)

Send your cover letter and cv to recruitment@BIGagainstbc.org