Job Description

Under the oversight of the line-manager, this role is responsible for comprehensive trial and siteadministration and involves preparing, collating, distributing, and archiving clinical documents. TheCTC-M supports clinical supply & non-clinical supply management and ensures timely maintenanceof tracking and reporting tools, as applicable.

The role is critical to meet planned Site Ready dates, including assisting with the preparation ofsubmission packages to IRB/ERC and Health Authorities. The role will collaborate at local levelclosely with COM, CRM and CRA. And the person collaborates with finance/budgetingrepresentatives to manage CTRAs and payments.

Responsibilities include, but are not limited to:

• Trial and site administration:

  • Provide expert assistance with data tracking and reporting tasks to various teams within the Site Management & Monitoring organization

  • Ensure collation and distribution of study tools and documents

  • Update clinical trial databases (CTMS) and trackers

  • Clinical supply & non-clinical supply management, in collaboration with other countryroles

  • Manage Labeling requirements and coordinate/sign translation change request, in collaboration with other country roles (if applicable)

• Document management:

  • 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

• Regulatory & Site Start-Up responsibilities:

  • Collaborate with other country roles to:

  • In a timely manner, provide to and collect from investigators forms/lists for siteevaluation/validation, site start-up and submissions

  • Obtain, track and update study insurance certificates

  • Support preparation of submission package for IRB/ERC and support regulatoryagencies submissions.

  • Publish study results for GCTO and RA where required per local legislation

• Budgeting, Agreement and Payments:

  • Collaborate with finance/budgeting representatives for:

  • Develop, control, update and close-out country and site budgets (including Split sitebudget)

  • Develop, negotiate, approve and maintain contracts (e.g. CTRAs)

  • Track and report contract negotiations

  • Update and maintain contract templates (in cooperation with Legal Department)

  • Calculate and execute payments (to investigators, vendors, grants)

  • 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

• Meeting Planning:

  • The tasks may include but are not limited to coordinating meetings and site visits, tracking, managing, and analyzing study data, and preparing reports.

  • Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)

Qualifications, Skills & Experience Skills:

• Fluent in Local Languages and business proficient in English (verbal and written) andexcellent communication skills
  Good understanding of Global, Country/Regional Clinical Research Guidelines and ability towork 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 abilityto 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 taskssimultaneously in a changing environment

• Works effectively in a matrix multicultural environment. Ability to establish and maintainculturally 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:

• Completed job training (office management, administration, finance, health care preferred) orBachelor's Degree.

ResearchandDevelopmentGCTO

MSJR

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Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe 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:R323669