Clinical Operations Lead

**Clinical Operations Lead**

**Company Overview**

**Position description**

MRM Health is looking for a Clinical Operations Lead to join and reinforce its Clinical Development Team in Ghent, Belgium, and translate pre-clinical and translational research into novel and differentiating products and, ultimately, breakthrough microbial strategies for the treatment of conditions associated to impaired intestinal health and immune, metabolic or CNS diseases.

Are you passionate about clinical development and do you have hands-on experience in the field of gut or inflammatory diseases? Are you looking to take on a key role in setting up and managing early clinical trials with a novel therapeutic modality? You will have the opportunity to become a key team member in MRM Health’s clinical development team to bring breakthrough live bacterial consortia to the patient in different diseases with high unmet medical need. Your initial focus will be on MH002, MRM Health’s clinical program in gut inflammation-associated disorders, yet you have the opportunity to be closely involved in the progression to the clinic of the other pipeline programs of MRM Health.

**Main tasks and responsibilities**:

- Responsible for the operational aspects during the planning, start-up, conduct and close-out phase of the given trial(s) while ensuring the quality and the integrity of the data (e.g. in line with GCP/ICH guidelines) and adhering to the agreed project timelines and budget.
- Translate protocol/project strategies from a concept into an executable study/project
- Act as first point of contact for Clinical Operations-related questions for the given trial(s).
- Provide regular updates on trial evolution to the Clinical Development Team, and escalate any significant issues which may have an immediate impact on patient safety or conduct of the study, timelines, budget and/or data quality.
- Contribute to timely development and/or review of trial-specific documentation (e.g., Protocol, Protocol amendments, trial-related vendor documents).
- Ensure the timely selection and qualification of CRO’s and vendors, their training and management throughout the study to ensure timely and quality deliverables.
- Identify risks and mitigation plans.
- Organize Kick-off Meetings, Investigators meeting and managing the CRO’s output and responsibilities.
- Operational implementation of trial protocol, including coordination of trial-related activities with both internal (medical, regulatory,) and external (CRO, central/referral labs) parties.
**Required Qualifications/Professional Experience**
- Having mínimally a Bachelor’s degree in a medical or biomedical discipline (e.g. pharmacy, biology, veterinary) or equivalent education/training.
- At least 5-10 years relevant experience in clinical research and drug development with at least 5 years of clinical trial management.
- Excellent knowledge of ICH, European directives and FDA guidelines related to GCP, experienced with adhering to SOPs and guidelines regarding the conduct of clinical trials.
- Experience with the clinical development processes, experience with immunology, gut and/or auto-immune diseases and/or living biological products is an asset.
- Demonstrated proficiency in Microsoft Word, PowerPoint and Excel; experience with MS Project (or similar) is an asset.
- Good organizational skills for seamless interactions with Study Teams, Investigators, Clinical staff, Vendors etc.
- Team player with good communication skills, personal leadership in matrix teas, flexibility and resilience, positive approach, forward thinking, conflict handling and problem solving skills, sense of innovation. Willing and capable to go the extra mile if needed.
- Being accountable: exercising judgement/impact of decisions/consequence of error.
- Able to manage multiple and varied tasks and prioritize workload with attention to detail.
- Fluent in speaking, writing and reading English.
We offer you the opportunity to grow and develop your competences and career in a rapidly evolving and dynamic environment. Your job title, level and salary will correspond to your education level, work experience, and skills.

**Job Types**: Full-time, Permanent contract

Schedule:

- Day shift
**Experience**:

- clinical trial management: 5 years (preferred)
Work Remotely:

- Temporarily due to COVID-19