Archer Research is looking for an experienced Clinical Research Professional (CRP) / Clinical Project Manager (CPM)!
Archer is a young, dynamic and growing Contract Research Organization (CRO) based in Bioville, Diepenbeek, Belgium. We are specialized in providing full support for clinical studies with medical devices in Europe.
As a CRP you manage and conduct clinical studies by respecting all regulatory requirements and Good Clinical Practice (GCP). You are the primary contact for sponsor and responsible to ensure the quality and integrity of the clinical data, together with Clinical Research Associates (CRA). You will manage multiple projects within different therapeutic areas, and you are able to work both independently and in a team environment.
You will have the opportunity to be involved in this constantly growing and inspiring international environment.
Who are we looking for?

• You have experience as a Clinical Research Professional or Clinical Project Manager in medical devices studies.
• You have a profound curiosity for clinical research & medical innovations.
• You are familiar with guidelines like Good Clinical Practice (GCP) and ISO standards (ISO14155, ISO9001).
• You can implement the EU Regulation for Medical Devices (EU MDR) in setting up clinical evaluations and clinical investigations, as well as post-market follow-up (PMCF) studies.
• The General Data Protection Regulation (GDPR) does not sound unknown to you.
• You have a Master’s degree or Ph.D. degree in one of the Life Sciences.
• You excel in clinical study planning, study budget management and medical writing.
• You love to travel and build strong (international) relationships with vendors, representatives and sponsors.

• You have excellent written and verbal communication skills including good command of Dutch and English. Knowledge of German and/or French is a plus.
• You have the ability to work predominately in our offices with the flexibility to work remotely from home.
• People describe you as being confident, flexible, pro-active and result-driven, with attention to detail and accuracy in work.
• You excel in effective time management and organization, with the ability to manage multiple priorities across various clinical studies within various disciplines and with a problem-solving mentality.
• Computer skills, including working knowledge of Microsoft Word, Excel, Power Point and Electronic Data Capture (EDC) systems are checked in your competences list.
  What is your role?
• Provide regulatory advice and support to sponsors (manufacturers) for setting up their clinical evaluation and clinical investigation, as well as PMCFs for their medical device in Europe.
• Prepare, coordinate and follow-up of ethical committee and/or national competent authority submissions in European member states.
• Develop Clinical Investigational Plan (CIP)/Protocol and Informed Consent Forms (ICF) according to the applicable regulations and guidelines.
• Select potential investigators by verifying the investigators’ interest, qualifications, training and resources.
• Coordinate (and conduct) international pre-study visits, site initiation and study close-out visits to ensure data integrity and patient safety on site.
• Coordinate (and conduct) clinical study monitoring (remote and on-site) to ensure adherence to the study protocol, Good Clinical Practice (GCP) in accordance with International Conference on Harmonization (ICH)-GCP standards, Declaration of Helsinki and Regulatory Requirements in order to guarantee data integrity, good documentation practice and patient safety.
• Support and advice CRA’s and investigators about study-related matters.
• Provide training to CRA’s, site staff as well as sponsor representatives about study-related matters.
• Coordinate planning and execution of investigator meetings.
• Assess and follow-up on patient recruitment and retention.
• Set-up and manage safety board and/or Imaging Core Lab.
• Ensure correct and timely Adverse Event (AE) and Serious Adverse Event (SAE) reporting and follow-up.
• Coordinate reconciliation of the Trial Master File (TMF) content to Investigator Site Files (ISF).
• Develop and manage (study-specific) clinical study documentation, including tools and templates.
• Writing of functional plans for clinical studies (CMP, SAP, DMP) as well as Clinical Study Report (CSR).
• Keep track of the study budget and report to sponsor and Clinical Operations Manager (COM).
• Create, implement and adhere to standard operating procedures (SOPs) for study execution.
  Interested to join the Archer Research team? Do not hesitate to send your CV to info@archerresearch.eu.

https://www.archerresearch.eu/jobs-projectmanager