Senior Clinical Research Associate

Job Description

If you want to:
•    Join a multi-award-winning leading biopharmaceutical company
•    Be part of growing team of Clinical Research Associates 
•    Use new technology and smart monitoring tools 
•    Have flexibility of work and good work-life balance
Apply today! 

On this position you will be accountable for performance and compliance for assigned protocols and sites in a country. You will act as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites and actively develop and expand the territory for clinical research, finding and developing new sites. 

Your key responsibilities: 
•    Conduct site visits (validation visits, initiation visits, monitoring visits, close-out visits) and record clear, comprehensive and accurate visit & non-visit contact reports.
•    Ensure by monitoring activities that: 
o    Data generated at site are complete, accurate and unbiased.
o    Subjects' right, safety and well-being are protected.
•    Perform clinical study site management/monitoring activities in compliance with local regulations, ICH-GCP, Sponsor SOPs, protocol, Site Monitoring Plan and associated documents.
•    Coordinate and manage various tasks in collaboration with other sponsor roles.
•    Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
•    Identify and assess site performance, quality or compliance problems in collaboration with CRA Manager, Project Manager, Therapeutical Area Head and Country Director as needed.
•    Manage and maintain clinical trial systems such as CTMS, eTMF, etc. 
•    Share the knowledge and best practices, nurture a learning culture to boost efficiency and competence of our team.
•    Follow the country strategy defined by Country Director.
 

You should apply if you have:
•    Min. 3 years of direct site management (monitoring) experience in a bio/pharma/CRO.
•    Proven skills in site management, including management of site performance and patient recruitment.
•    Good IT skills, ability to learn and operate new IT applications. 
•    Ability to understand and analyse data/metrics. 
•    Capable of managing complex issues, works in a solution-oriented manner.
•    Fluent in English (verbal and written) and local language, excellent communication and presentation skills.
•    Good understanding and working knowledge of clinical research, local regulations, ICH-GCP.
•    M.A/ M.Sc degree with strong emphasis in medical/bioscience background.
•    Ability to travel domestically and internationally approximately 50% of working time. Expected travelling ~2-3 days/week.
•    Valid driving license.
 

Current Employees apply HERE

Current Contingent Workers apply HERE

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

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