เงื่อนไขการค้นหา

ทักษะ:

Compliance, Research, Excel, English

ประเภทงาน:

งานประจำ

• Track (e.g. essential documents) and report (e.g. Safety Reports).
• Update clinical trial databases (CTMS) and trackers.
• Ensure collation and distribution of study tools and documents.
• Clinical supply & non-clinical supply management, in collaboration with other country roles.
• Manage Labeling requirements and coordinate/sign translation change request, in collaboration with other country roles (if applicable).
• Prepare documents and correspondence.
• Collate, distribute/ship, and archive clinical documents, e.g. eTMF.
• Assist with eTMF reconciliation.
• Execute eTMF Quality Control Plan.
• Update manuals/documents (e.g., patient diaries, instructions).
• Document proper destruction of clinical supplies.
• Prepare Investigator trial file binders.
• Obtain translations of documents.
• In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions.
• Obtain, track and update study insurance certificates.
• Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.
• Publish study results for GCTO and RA where required per local legislation.
• Ensure adherence to financial and compliance procedures.
• Monitor and track adherence and disclosures.
• Maintain tracking tools.
• Obtain and process FCPA documentation in a timely manner.
• Organize meetings (create & track study memos/letters/protocols).
• Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable).
• 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.
• Effective time management, organizational and interpersonal skills, conflict management.
• Effective communication with external customers (e.g. sites and investigators).
• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
• Demonstrates commitment to Customer focus, both internally and externally.
• Able to work independently.
• Proactive attitude to solving problems / proposing solutions.
• Positive mindset, growth mindset.
• Qualification & Experience:Bachelor s Degree (health sciences, healthcare preferred).
• 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.
• Regular
• Not Applicable
• 10/18/2024A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
• Job Posting End Date:10/18/2024.
• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
• Requisition ID:R308103.