Job Description

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:

(1) Trial and site administration:

o Track (e.g. essential documents) and report (e.g. Safety Reports)

o Ensure collation and distribution of study tools and documents

o Update clinical trial databases (CTMS) and trackers

o Clinical supply & non-clinical supply management, in collaboration with other country roles

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

(2) Document management:

o Prepare documents and correspondence

o Collate, distribute/ship, and archive clinical documents, e.g. eTMF

o Assist with eTMF reconciliation

o Execute eTMF Quality Control Plan

o Update manuals/documents (e.g., patient diaries, instructions)

o Document proper destruction of clinical supplies.

o Prepare Investigator trial file binders

o Obtain translations of documents

(3) Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to:

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

o Obtain, track and update study insurance certificates

o Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.

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

(4) Budgeting, Agreement and Payments:

Collaborate with finance/budgeting representatives for:

o Develop, control, update and close-out country and site budgets (including Split site budget)

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

o Track and report contract negotiations

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

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

o Ensure adherence to financial and compliance procedures

o Monitor and track adherence and disclosures

o Maintain tracking tools

o Obtain and process FCPA documentation in a timely manner

(5) Meeting Planning:

o Organize meetings (create & track study memos/letters/protocols)

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

Current Employees apply

Current Contingent Workers apply

Secondary Language(s) :

Skills:

• 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:

• Completed job training (office management, administration, finance, health care preferred) or Bachelor\xe2\x80\x99s Degree

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Employee Status: Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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Merck Sharp & Dohme