Medical Monitor
Linical Co
United Kingdom
12d ago

Job Id. MMO-UK-20180226

Location(s) : United Kingdom

Company Name : LINICAL

Industry : Contract Research Organization

Job Type : Full-Time

Job Duration : Indefinite

Salary : Competitive (according to the candidate’s value)

Benefits : Competitive

Linical Co. , Ltd. ( Linical’) is a premier global CRO headquartered in Osaka, Japan, listed in the prime segment of the Tokyo Stock exchange, and dedicated to serve its clients as a true partner in development.

With approximately 900 employees Linical directly covers a total of more than 20 countries in Europe, North America and Asia-

Pacific including Japan via its own offices and staff.

Linical’s European arm is headquartered in Frankfurt, Germany with a substantial presence in Paris and Madrid. Its geographic footprint facilitates a significant presence in the leading Western European markets, combined with well-

established affiliate operations in key emerging markets in Central- and Eastern Europe.

We offer individualized solutions that are tailored to the specific needs of our sponsors. We work as integrated teams functioning with maximum transparency throughout each study, making sure that the sponsor is kept up to date on all study parameters and progress.

We are dedicated to the highest standards of quality, with a special focus on the therapeutic areas oncology, immunology and CNS, based on experience and expertise.

Pharma Resourcing Solutions PRS :

Linical Pharma Resourcing Solutions (Linical PRS) has the experience and a clear understanding of the importance of our clients’ resourcing strategies.

With the flexibility that this level of service requires, Linical is able to serve a full range of resourcing requirements as per our clients’ needs and expectations.

Linical PRS is supported by a strong and continuous recruitment activity, accompanied by qualified and highly experienced line management personnel as well as strong leadership oversight throughout the process.

Thus, PRS can guarantee success and commitment to the project objectives of our clients.

We truly believe people are the real value of a company and we invest in their performance and their professional satisfaction.

Scope of the role :

The Medical Monitor (MM) is responsible for the development, execution and subsequent interpretation of data for GMAF (Global Medical Affairs) conducted studies in collaboration with the Global Program Director and / or Study Manager.

With strategic input from the Global Medical Lead (GML) members of the Product Matrix team. Through the GML the MM will incorporate cross-

functional input from Core Team and GMAF Matrix Team. The Medical Monitor partners with study management, data analytics and other relevant cross functional teams to ensure GMAF sponsored studies are managed according to plan and in accordance of Good Clinical Practice guidelines.

Key Responsabilities :

Responsibilities may include, but are not limited to :

Provide Medical Affairs Scientific Support and Medical Monitoring for Medical Affairs Clinical Studies :

Strategy and Planning

With oversight from the Global Medical Lead (GML) acts as the medical lead for development / design and medical monitoring of medical affairs managed studies including post-

marketing commitments and post-marketing requirements / in collaboration with the Global Program Manager and / or study manager including :

  • Understanding and guidance for the development of study protocol objectives, scientific rationale, methodology, procedures and the impact on patients through the life of the study
  • Incorporate scientific information concerning a product and disease into a study design
  • Work with outside experts when needed on study design
  • Identify and define protocol objectives, methodology, biostatistical concepts and data analysis as needed for effective study execution
  • Research, design and write the background, objectives, the non-statistical study design, sections of the protocol in collaboration with study team
  • Understand the scope of information needed for inclusion into regulatory deliverables
  • Contribute to site selection, investigator meetings, safety monitoring, data review activities, and reporting
  • Represent study team at appropriate governance meetings (eg, Protocol Review Committee), clinical meetings, brand planning activities, business reviews
  • Participate in strategic planning of communication of study results
  • Execution of Medical Affairs Sponsored Studies

    In collaboration with the study manager and members of the cross-functional study team

  • Review and reconcile Adverse Events (AE) in collaboration with Pharmacovigilance and GMAF Study Management
  • Support development of periodic reports sent to regulatory agencies (eg Periodic Safety Update Report, PMR required reporting)
  • Liaise with study / program steering committee, data safety monitoring committees, and publication committees
  • Assist in critically evaluating study results in statistical and final reports and ongoing reviews with study investigators and other cross functional groups
  • Address questions from study sites, site Ethics Committees / Institutional Review Boards and local regulatory agencies as they relate to the study(ies) being conducted
  • Participate in the preparation of reports and presentations to management and the medical community
  • Anticipation of potential issues in study conduct and help to prevent and / or resolve them
  • Attend investigator meetings as the medical expert for the study, provide ongoing support at other study related meetings
  • Advise and support study investigators as needed
  • Understand the fundamental techniques and principles of interpreting safety and efficacy data including the principles and techniques of data analysis, data interpretation and clinical relevance
  • Select in collaboration with the study statistician the appropriate statistical approach for the interpretation of datasets
  • Provide oversight and direction for data cleaning, data analysis and interpretation
  • Evaluate, interpret and present complex and difficult data for a series of studies (prospective and retrospective)
  • Serve as the resource for final interpretation, approval of results
  • Study related Communication and Information sharing

  • With an understanding of the product safety profile contribute to the safety sections of the Investigator brochure (when relevant in for pre-
  • market products) and annual reports

  • Provide input and review to communication strategies and publications from the studies
  • Support data dissemination plans for the trials set forth by the GML in conjunction with Matrix team
  • Qualifications and competencies required :

  • It is expected that the Medical Monitor has the experience and knowledge required to adopt and demonstrate medical and scientific knowledge in product and disease area in question;
  • foundational skills in strategic thinking and planning; effective communication and collaboration; thorough understanding of Good Clinical Practice, Good Pharmacovigilance Practice, and other methods or regulations relating to high quality data generation.

  • MD with country licensure or fellowship; or Pharm D preferred; BS level degree in life or health sciences required
  • More than 2 year experience in pharmaceutical / biotechnology industry in clinical science, medical affairs, and / or drug development is preferred
  • If no industry experience available ³2 year research experience is required
  • Are you ready for the challenging and exciting work within an international team, in a well-established but also fast growing CRO?

    Are you target-driven, used to sharing your expertise with a team and always focused on the team’s success?

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