Job Description

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CATO SMS and Pharm-Olam, LLC have merged to form Allucent!

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. The Medical Director (MD) oversees the medical and the safety aspects of assigned clinical trials managed by Allucent and provides medical and scientific clinical research expertise into the direction, planning, and interpretation of clinical trials/research and the data collection activities and is responsible for safety review and answering of study-related medical questions of Allucent. The MD is a member of the Medical staff.

Medical Monitoring:

• Oversee the medical and safety aspects of assigned clinical trials managed by Allucent including adverse events, safety reporting and laboratory testing. When appropriate, assist the Project Manager in discussions with clients on safety issues or concerns that may have arisen.
• Provide input on: o Protocol design o Strategic clinical recommendations
• Prepares the Medical Monitoring and other relevant plans for assigned studies conducted by Allucent prior to the start of the study
• Medically monitor clinical studies, which includes the review of Case Report Forms (CRFs) to ensure adherence to the protocol and consistency and scientific validity of the data
• Assists with protocol interpretation in assigned projects and as needed, contacts appropriate team members to ensure appropriateness of decisions arising from such interpretation
• Conduct safety reviews to identify data issues, to evaluate data for safety and efficacy and to interpret trends
• Provide medical and scientific guidance to study site personnel to ensure consistency in interpretation and exchange of scientific information in clinical trials
• Answer medical or technical questions concerning protocol and product
• Review Serious Adverse Events, SUSARs, safety narratives and perform Analysis of Similar Events
• Reviews clinical laboratory data on assigned studies for safety tends or signals detection Assists clinical data management with MedDRA and WHO coding in assigned studies
• Assists by reviewing the clinical study report (CSR) in assigned projects and other safety reports including post marketing reports (e.g., PSUR)
• Independently assists in the set up and conduct of Data Safety Boards (DSMB, DMB or similar) and Dose escalation meetings (DEC)
• Provide team training on study indication and protocol as required
• Participate in Investigator meeting, Scientific Advisory Board (SAB) meetings
• 24/7 medical support as required - Medical and Safety advice
• Training of project teams
• Review of Protocol Deviations
• Review of Medical coding
• Draft and contribute as Subject Matter Expert (SME) in the field of Medical Monitor activities to the evaluation/improvement of processes and procedures within the Quality Management System

• Support Business Development efforts by reviewing the proposal, the budget and attending client meetings including Bid Pursuit Meetings
• Assure good communication and relationships with (future) clients
• Contribute and take part in client evaluations, visits and bid defenses
• May advise and assist clients on product development, study designs, endpoint analyses and the feasibility of conducting Phase I to IV clinical trials in countries proposed by Allucent. Liaise with country managers and department heads at Allucent as needed to meet this task
• May provide therapeutic consultation in support of the scientific, medical, and regulatory operations of the company, including medical assessments on a consultative basis for post marketing activities (e.g., product labelling, health hazard evaluations, etc.)
• Attends and presents at major therapeutic conferences and drug development conferences
• Mentors other medical staff within the department

• MD degree
• Minimum 7 year of relevant work experience
• Basic knowledge of GxP Good standing with local, state (in the US), and national licensing and regulatory authorities and certifying bodies
• GDPR/HIPPA, CFR/CTR/CTD and applicable (local) regulatory requirements

• Strong written and verbal communication skills including good command of English language
• Representative, outgoing and client focused
• Ability to work in a fast-paced challenging environment of a growing company
• Administrative excellence
• Proficiency with various computer applications such as Word, Excel, and PowerPoint required
• Accurate and detail orientated

• Medical Monitoring experience
• Located in USA or Canada (Eastern Standard Time or Central Standard Time)