Spclst, Clinical Research

Job Description

• 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:
  • Data generated at site are complete, accurate and unbiased.
  • 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. 1 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

Search Firm Representatives Please Read Carefully 
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:

Hazardous Material(s):

Required Skills:

 Preferred Skills:

Job Posting End Date:

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