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You are viewing Senior Medical Director – Oncology – Americas (US, Canada, LATAM) – Home-based at Worldwide Clinical Trials Remote-based
Full time
Job Description
What you will do
- Medically manage clinical trials to which s/he is assigned as Medical Monitor, serve as Global Lead Medical Monitor (GLMM) for pan-regional and/or global trial(s) to which s/he is assigned; provide after hours medical support for projects to which s/he is assigned
- Collaborate with the other members of the Medical & Safety project teams to process Serious Adverse Events (SAEs); demonstrate competence with the execution of SAE related medical review in WORLDWIDEs electronic safety database
- Provide therapeutic and protocol-specific training to the project teams; contribute medical input into the design of clinical development programs, study protocols, research papers, client focused white papers, etc.; independently support Business Development through participation in proposal generation, feasibility assessments, review of proposals/contracts for medical services, and attendance at meetings with sponsors as directed by department senior management; assist in the annual attainment of departmental revenue targets and any other activities as directed by senior management; mentor other medical staff as directed by Senior management and by consistently displaying exemplary work ethics, compassion and integrity, supports Senior Management’s leadership of both the department and the company
- Review and/or assist in the preparation of final study reports (CSRs), or other study documentation (Protocols, ISS/ISEs etc.,) as directed by senior management; maintain a high level of competence with assigned projects, including knowledge of project and therapeutic advances as well as marketplace developments by participating in internal meetings (company-wide project tracking, medical management meeting, etc), review of relevant therapeutic/clinical literature and attendance in conferences and meetings; interact with staff in other functional areas within the company to ensure the highest level of client satisfaction through successful execution of projects; identify, document and appropriately resolve out-of-scope work as directed by senior management
What you will bring to the role
- Strong supervision, interpersonal and communication skills as well as conflict resolution skills and be committed to quality and honesty
- Must possess exceptional organizational and planning skills and good documentation skills.
- Must be punctual and have a flexible work schedule.
- In-depth knowledge of the clinical research process, including Good Clinical Practices. Working knowledge of GCPs and regulatory requirements relating to clinical development and safety assure compliance with ethical, legal and regulatory standards. Clinical/therapeutic acumen in medical subspecialty through online and/or in person scholarly programs/lectures
- Able to make good, sound decisions under stress and time constraints.
- Possible equipment includes, but is not limited to: microscope, computers, rolling carts, fax machines, photocopiers, telephone, lab apparatus, mop/broom, needles, spirometry, centrifuges, and allergy testing equipment, scales, calculators, vital signs equipment, ECG equipment, defibrillator, suction device, pipettes, ophthalmoscope/otoscope and other medical equipment.
Your background
- A Medical degree (M.D.) with a specialization (board certification) in Oncology
- 6-8 years of medical monitoring in the CRO, Pharma or Biotech industry with the medical monitoring or study physician role role
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