Clinical Project Manager / CRA Manager

Location Ghent
Discipline: Clinical Operations
Job type: Permanent
Contact name: Joe Pearce

Contact email: joe.pearce@rbwconsulting.com
Contact phone: +44 (0) 1293 584 300
Job ref: CPM / CRA Manager
Published: 2 months ago
Expiry date: 20 Mar 2024 23:59

  • Job Title: Clinical Project Manager / CRA Team Lead

  • Company: Small CRO

  • Location: Hybrid in Flemish Region (2 times a week in the office)

  • Salary: Flexible depending on candidate experience (driven by the market and discussed further upon application)

RBW Consulting are excited to announce an opportunity on behalf of one of our close clients. This company are a small CRO that partner with niche Biotech’s on studies across the Benelux region. They have recently expanded their team in the Netherlands with a new office being opened which highlights their continued growth and success. Due to the size of this company and their flat structure, career progression is easily achievable with the support of promotions & growth from within.

On the one hand, you are responsible for the end-to-end management of our full-service clinical trials, which means that you not only manage the Clinical Operations part, but also the activities for medical writing, regulatory activities, data management, statistics, pharmacovigilance, medical monitoring, …

On the other hand, you are responsible for a team of (currently) 8 CRAs. You are involved in selection, onboarding, training and coaching of our CRAs. In close collaboration with the Clinical Operations Manager and QA Coordinator, you contribute to the improvement of our processes.

Responsibilities

As Project Manager:

  • To bear full responsibility for a clinical trial in terms of progress, timelines, capacity and quality.

  • To coach and supervise the project team.

  • Act as main line of communication between sponsor, site staff and any third party.

  • To ensure that the trial is conducted and documented in compliance with the approved protocol/amendment(s), with Good Clinical Practice (GCP) and with all applicable regulatory requirements.

  • To work according to the applicable quality management system (in house or client).

As CRA Team Lead:

  • To manage resourcing, staff retention, training and capacity needs.

  • To manage performance and skills development of all internal CRAs.

  • To ensure accurate identification and implementation of client and project requirements.

  • To bear end responsibility for all aspects of delivered monitoring services.

  • To stay abreast of new developments and regulations in the industry and ensure that operational processes and standards reflect those developments.

  • To ensure close communication and coordination between CRAs and PMs.

Tasks

As Project Manager:

  • To set up the required structures for a clinical trial (administrative and operational).

  • To plan and manage the project timelines and resources in accordance with the project budget.

  • To ensure the study team is sufficiently trained and that everything is in place for the study team to perform the activities.

  • To ensure all required trial documents are available (protocol, ICF, manuals, guidelines, …).

  • Coordination and planning of capacity, timelines, … to achieve qualitative and timely results.

  • To supervise the progress of the trial (recruitment, monitoring, …).

  • To ensure adequate collection and filing of all study (essential) documents.

  • To coach and supervise the project team.

  • To supervise the performance of vendors.

  • To report adequately and timely the progress of the study to company management and client.

  • To proactively discuss any issues which might arise in future (e.g. regarding recruitment, timelines, …).

  • To escalate timely any issue and propose the necessary actions.

  • To highlight out of scope activities to Business Development.

As CRA Team Lead:

  • To ensure adequate training programs (introductory and during employment) for the CRAs.

  • To supervise capacity planning for monitoring activities.

  • To perform co-monitoring visits.

  • To act as first-line helpdesk for the CRAs.

  • To follow-up on the quality of the monitoring activities.

  • Any required activity to ensure a good integration of both Belgian and Dutch team of CRAs.

  • To review and improve existing SOPs and to develop new SOPs if needed for monitoring activities.

Requirements

  • Degree in life science, preferably higher vocational education or academic degree

  • Fluent in English and Dutch; another European language is an asset

To apply:

If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone on +44 (0) 1293 584 300

Please click ‘apply’ or contact Joe Pearce for any further information

About RBW Consulting

RBW Consulting is a life sciences talent & strategic consultancy with purpose, delivered through what we call Human Intelligence. We help life sciences businesses change the world by giving them the people, insight & networks to innovate and scale. We are proud of our role in helping companies deliver better health and wellbeing outcomes for patients We give back by playing an active role in funding initiatives that change lives We’ve created a culture rooted in support, transparency and mutual commitment. We lead with our values from the inside; empowering and investing in our people is more important than short-term commercial gain.

We are an equal opportunities Recruitment Business and Agency

RBW Consulting is an equal opportunity workplace. We prioritize talent (both current and potential) over resumes, challenge the status quo, and value people as our most important asset. We do not discriminate on the basis of race, ethnicity, colour, sex, gender identity or expression, sexual orientation, religion, age, marital status, visible or invisible disability, medical condition, national origin, veteran status, or any other protected status. We strive to be a diverse workforce that is representative at all levels and are committed to building a team that represents a variety of backgrounds, perspectives, and skills.