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 :
Execution of Medical Affairs Sponsored Studies
In collaboration with the study manager and members of the cross-functional study team
Study related Communication and Information sharing
market products) and annual reports
Qualifications and competencies required :
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.
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?