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Job Details

Medical Monitor - Internal Medicine - Bratislava, Slovakia

Company: Premier Research
Location: Bratislava, Slovakia
Reference: 853LH
Closing Date: 01 Mar 18
Type: Full Time
Salary (£): Competitive
Benefits: Comprehensive

Job Summary:

Premier Research is a well established and reputable global Contract Research Organisation (CRO) who help innovative biotech and specialty pharma companies transform life-changing ideas into reality. Exciting, newly created opportunities exist for qualified physicians new to industry with good clinical or prior CRO experience to support our growing scientific team with medical oversight of studies and medical data review.

Requirements:

POSITION SUMMARY:

Responsible for providing scientific support to Premier Research in business. Supports study related medical monitoring activities that are led by the medical directors in accordance with regulations and SOPs, in particular focusing on medical data review.

Neurology, oncology, pediatric, psychiatry or dermatology experience preferred.

These are excellent opportunities for medics to entry the clinical research industry and apply their medical knowledge directly.  Training and mentoring will be provided on the job.

Candidates should be able to offer fluency in written and spoken English, possess an excellent eye for detail and be confident and accountable for making independent decisions.

These positions can be offered in either our Warsaw, Poland or Bratislava, Slovakia office locations.  

The Medical Monitor:

  • Is responsible for setting up, documenting and communicating project specific medical monitoring requirements for assigned projects.
  • Supports medical monitors under medical guidance in the conduct of studies
    • Develops and reviews medical monitoring and other study related plans
    • Trains project team and sites in the protocol
    • Reviews site and project team queries
    • Reviews medical data including labs, patient profiles, CRF data and eligibility/enrollment reviews
  • Assists Medical Monitors in business development
    • Performs scientific research for and provides input into the RFP

RESPONSIBILITIES: 

  1. For High Quality Medical Support:
  • Conducts medical data review and generates data queries
  • Ensures compliance with and adherence to all internationally recognized standards (e.g. ICH GCP, ICH E2A, ISO14155, etc.), national regulations and SOPs applicable for specific projects.
  • Provides support to Medical Directors with their Medical Monitoring activities.
  • Initiates medical monitoring activities during the start-up of clinical trials including development of process documents aligned with the study protocol, budget, standard operating procedures, and ethical requirements.
  • Writes and reviews Medical Monitoring Plans.
  • Reviews budget and scope of medical team’s responsibilities addressing inadequacies or concerns with the Medical Director and/or project management team.
  • Tracks study progress, proactively resolves issues, and proposes corrective action to project team/clients.
  • Processes and addresses protocol non-compliances at Investigative sites and ensures adherence to ethical guidelines
  • Collaborates with Medical Directors on the medical-operational aspects of complex clinical studies
  • Attends Investigator Meetings and interacts with Investigative site staff and client representatives
  • Is a point of contact and knowledge resource for Medical Directors to consult with on study-specific drug/device medical activities
  • Works closely with Medical Directors/Investigative Sites/CRAs to document and assist with resolution of clinical issues, e.g. continuing eligibility queries
  • Reviews study documentation (e.g. budget, protocol, CRF, DSMB charter, etc.)
  • Supports implementation and use of new technology tools
  • Prepares for audits and inspections by sponsors or regulatory agencies
  • Participates in internal and external project team and client meetings
  • Represents the department and interfaces with other departments, as needed (e.g. with data management, clinical operations, etc. 
  1. For Commercial Success:
    • Ensures activities are carried out to a high standard and as efficiently as possible with proactivity and customer focused delivery 
  1. Other
  • Reviews and QCs documents and work of other associates, as needed
  • Mentors other more junior members of the team
  • Participates in corporate initiatives and actions that ensure the continued success of the company
  • Supports PV activities as needed
  • Other activities as designated

EDUCATION, SKILLS & COMPETENCIES: 

  1. Educational Background
  • Graduate in medicine, or equivalent
  • Ideally, previous clinical practice experience in oncology, dermatology, pediatrics, or neuro-psychiatry is preferred (Board certification or equivalent not required).
  • CRO experience in an alternative function is preferred (e.g. CRA, data management)
  • The above education requirements may be waived if existing exact-match work experience is present and deemed to be sufficient.

 Expertise and know-how:

  • Knowledge of ICH / GCP regulations ideal
  • Working knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures
  • Knowledge of web-based communication tools for conferences 
  1. Personal skills & behaviours
  • Fluent verbal and written English as well as the local language(s)
  • Excellent team player, collaborative and able to build an effective team.
  • Ability to multi-task and work effectively in a fast-paced environment with changing priorities.
  • Strong verbal and written communication and negotiation skills.
  • Excellent organizational and time-management skills, able to prioritize workload to meet deadlines.
  • Is accountable, dependable and demonstrates strong commitment.
  • Is customer service focused in approach to work both internally and externally.
  • Maintains a positive, results orientated work environment.

 

Apply for this job: Medical Monitor - Internal Medicine - Bratislava, Slovakia

Contact Information:

Address:  European Headquarters
1st Floor,
Rubra 2
Mulberry Business Park,
Wokingham,
RG41 2GY
England
View our Profile Page
Tel:  +44 (0) 118 936 4000
Fax:  +44 (0) 118 936 4001
Website:  Visit Our Web Site

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