Job Requirements

This posting has been created to pipeline talent for prospective roles that we anticipate will be needed soon in our organization. By applying to this Pipeline Advertisement you will be submitting your interest to be contacted for roles similar to what is described in the Pipeline Advertisement.

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!  

In this role, 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. 
Work Experience

You should apply if you have: 

Min. 1 year of experience in clinical trials.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. 

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. 

Requisition ID:P-100797