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. e TMF.
Assist with e TMF reconciliation.
Execute e TMF 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.
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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.
Regular
Not Applicable
11/29/2024A 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.
Requisition ID: R308103.
Job skills required: Excel, English, Research, Compliance
Job skills preferred: Finance, Negotiation