Senior Associate, Clinical Research

Job Description

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)

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

• 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

• 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

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

o Support local investigator meeting

• 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

Current Employees apply HERE

Current Contingent Workers apply HERE