Trial and site administration : Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents.
The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.
The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to IRB / ERC and Health Authorities.
The role will collaborate at local level closely with COM, CRM and CRA. And the person collaborates with finance / budgeting representatives to manage CTRAs and payments.
Responsibilities include, but are not limited to :
Trial and site administration
Regulatory & Site Start-Up responsibilities
Budgeting, Agreement and Payments
Qualification & Experience :
Completed job training (office management, administration, finance, health care preferred) or Bachelor’s Degree
Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
Good understanding of Global, Country / Regional Clinical Research Guidelines and ability to work within these guidelines.
Hands on knowledge of Good Documentation Practices
Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications.
Strong MS Excel skills required.
ICH-GCP Knowledge appropriate to role
Excellent negotiation skills for CTCs in finance area
Current Employees apply
Current Contingent Workers apply
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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 : Regular
Relocation : No relocation
VISA Sponsorship :
Travel Requirements :
Flexible Work Arrangements :
Valid Driving License :
Hazardous Material(s) :
Number of Openings :