13 Jan, 2022

Contract Oncology Medical Monitor - APAC Region

  • Admin
  • Remote
Contract Medical-Nursing Pharmaceutical Research Science

Job Description

SUMMARY: To provide medical management and professional medical support for clinical research projects at [Hidden]* as the assigned Medical Monitor (MM). To assist in activities requiring Medical & Scientific support, including but not limited to: assistance with feasibility assessments, medical training and provision of medical/clinical input to the design of study protocols and/or clinical development programs as well as assistance with business development activities, as directed by the department head.  

Medical monitoring of phase II/III clinical trials and therapeutic expertise in Oncology is required. This an APAC based contract role. 

RESPONSIBILITIES:

  • Medically manages clinical trials to which s/he is assigned as MM
  • Serves as Global Lead MM (GLMM) for pan-regional and/or global trial(s) to which s/he is assigned
  • Collaborates with the other members of the Medical & Safety project team to process Serious Adverse Events (SAEs)
  • Provides therapeutic and protocol-specific training to the project teams
  • Contributes medical input into the design of clinical development programs, study protocols, research papers, client-focused white papers, etc.
  • Provides after-hours medical support for projects to which s/he is assigned
  • Independently supports 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
  • Reviews and/or assist in the preparation of final study reports (CSRs), or other study documentation (Protocols, ISS/ISEs etc,) as directed by senior management
  • Maintains 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
  • Interacts with staff in other functional areas within the company to ensure the highest level of client satisfaction through successful execution of projects
  • Identifies, documents and appropriately resolves out-of-scope work as directed by senior management
  • Assists in the annual attainment of departmental revenue targets and any other activities as directed by  senior management 
  • Maintains working knowledge of GCPs and regulatory requirements relating to clinical development and safety  assure compliance with ethical, legal and regulatory standards
  • Mentors other medical staff as directed by Senior management and by consistently displaying exemplary work ethics, compassion and integrity, support Senior Management’s leadership of both the department and the company
  • Maintains clinical/therapeutic acumen in medical subspecialty through online and/or in-person scholarly programs/lectures
  • Demonstrates competence with the execution of  SAE related medical review in [Hidden]* electronic safety database 

REQUIREMENTS:

  • Medical Degree from an accredited institution of Medical Education.
  • 2+ (Medical Director level) - 6+ (Sr. Medical Director level) years in the CRO, Pharma or Biotech industry with the medical monitoring or study physician role.
  • Experience medical monitoring phase II, III clinical trials. 


#LI-EW1 #LI-Remote #oncology

 

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Remote Status

Onsite Requirements (e.g. Training, meetings etc) (Please see listing for details - contact employer for further information)

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