Clinical Research Manager

1 post / 0 new
Amar Annamalai
Amar Annamalai's picture
Clinical Research Manager

Merck plays an integral part in the life science community, harnessing our passion and innovation to help researchers and drug producers around the world. As science advances, we advance with it, offering new insight and cutting-edge technologies helping our customers solve the world’s most challenging human health issues.

 
Our promise to our customers is that we’ll be there every step of the way. If you share our goals and values, and want to make your mark at a rapidly growing international company, join us and help advance the future of life science together. Merck KGaA. Merck is a global pharmaceutical and chemical company with a history that began in 1668, and a future shaped by around 40,000 employees in 64 countries around the world.
Merck Serono is the division for innovative small molecules and biopharmaceuticals of Merck KGaA and consists mostly of Research, Clinical, Marketing, Support Functions and the DivisionalManagement.
 We are looking for a:

Clinical Research Manager - UK (m/f)


KEY ACCOUNTABILITIES
Accountable for day to day activities of all aspects for the management of local company-sponsored studies, including study plans, timelines, resources, problem identification and resolution, status reports and budget to ensure timely delivery of completed study reports to the project teams
Manage independent consultants including CROs, clinicians, independent CRAs, or statisticians when required by the project including selection, coordination of project specific training, and payment
Develop and monitor study budget and timelines
Monitor work to ensure quality
Ensures that trials are entered into the Clinical Trial Management System (SWAN) and other systems, if applicable
Understanding of local / country requirements for clinical trials
Managing and steering CROs
Networking skills to represent Merck Serono with key local stakeholders
Proactive issue monitoring and management
 
FINANCIAL DIMENSION
Manages the budget for all local clinical studies and Global Phase IV studies assigned
 
STRATEGIC IMPACT
Coordinate within own country study management for all local clinical trials across all phases and therapy areas and for Global Phase IV trials
Support local organization in delivering local medical strategy across the portfolio within own country
Work with CRO in county to ensure local trials are delivered within desired quality, timeline.
 
SCOPE OF PEOPLE RESPONSIBILITY
Overseeing external providers and act as interface between Global Clinical Operations and local organization (Global Operations)

COOPERATION
Internally
Country organization
Medical Affairs (HQ and country)
Clinical Account Manager
CSSP
Legal
Finance
CCSO - Financial planning and analysis
CCSO - Clinical Operations Lead (for Global Ph IV trials)
Externally
CROs and other service providers
Medical experts/Key Thought Leaders
Investigators and clinical site personnel
Representatives of institutions/hospitals  
 
EDUCATION
Medical or Life Sciences degree or equivalent qualification

 
WORK EXPERIENCE
At least 3 years of experience in clinical research in a CRO, pharma or biotech company
Experience in clinical trial planning and conduct and thorough knowledge of ICH GCP and applicable local regulations
 
JOB-SPECIFIC COMPETENCIES & SKILLS
Demonstrated good interpersonal skills
Demonstrated good written and verbal communication skills
Demonstrated good presentation skills
Demonstrated ability to handle and oversee multiple tasks simultaneously and to prioritize in meaningful way
Analytical skills, quick perception and good judgment
Fluency in English (oral and written) plus local language  

 
Job number: 1300889

Deadline: Contact employer

For more details