Clinical Research Associate At Minapharm Pharmaceuticals
About Minapharm
Minapharm Pharmaceuticals is a leading pharmaceutical company in Egypt and the Middle East with its subsidiary Rhein Minpahrm Biogenetics the premier biopharmaceutical company in Africa with over 20 years of experience in cellular and bioprocess engineering. Headquartered in Cairo, Minapharm commercializes over 100 life-saving and life-enhancing products ranging from small molecules to complex genetically engineered proteins, with an impressive immunotherapy pipeline. Minapharm’s wholly-owned Berlin-based subsidiary, ProBioGen AG, is a world-renowned contract development and manufacturing organization (CDMO), a cell line-engineering specialist, and a provider of proprietary protein and viral vector technologies to large pharma and the global biotech industry. Minapharm has established an integrated business model making it to date the only gene-to-market biopharmaceutical company in the region. Minapharm employs a collective workforce of over 1400 individuals.
Duties:
Responsible for the management of designated clinical trials including investigator selection, analysis of potential patient recruitment, preparation of trial-related documentation (protocols, Case report forms, investigators brochures, consent documents, letters of agreement, confidentiality agreements), organizing Ethics committee submissions with follow through to ensure a successful outcome.
Organize investigator’s start-up meeting and study site initiation meetings.
Coordinate the movement of laboratory samples and the resulting data when central laboratory facilities are used.
Ensure procedures are in place for the appropriate optimization of patients into the clinical trial.
Monitoring the assigned clinical trial following company SOPs and in accordance with GCP.
Planning the requirements for clinical trial material, ordering clinical trial material (head office or local comparators), setting up and monitoring the systems whereby the Clinical Research Assistant can ship CT material to the investigator, maintaining procedures to account for the CT material, checking the expiration of CT material and requesting extensions if necessary.
Tracking completed CRFs and setting up systems whereby completed CRFs are rapidly entered into the database. Ensure that queries generated during cleaning are responded to in a timely fashion.
Manage patient recruitment strategies to increase patient randomization into the trial (e.g.: investigator and research nurse meetings, update newsletters, advertising, letters to GPs).
Review all SAEs, ensure Medical Director sign-off, that sites are notified and that all company procedures are complied with.
Manage the Contract Research Organizations – initial identification of a suitable partner, the definition of CRO responsibilities, communication plan, divisions of responsibility, milestones, contract with CRO, review monthly status reports, and the interactive management of CRO to ensure project success.
Requirements:
Physician/ Pharmacist
Previous experience in the same position not less than 1 year in a pharmaceutical company.
Self-organizing skills.
Communication skills to all levels of staff.
Analytical skills with attention to detail.
Flexibility according to the needs of the processes.