Senior Associate, Clinical Research in Gurgaon, भारत

Senior Associate, Clinical Research

Responsibilities include, but are not limited to:

• 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)

• 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

• 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

Meeting Planning:

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

o Support local investigator meeting

Key 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

Additional location(s) Compensation Information:

Required Skills:

Accountability, Accountability, Analytical Problem Solving, Budget Development, Clinical Data Management, Clinical IT, Clinical Research, Clinical Trial Compliance, Clinical Trial Documentation, Clinical Trial Management, Clinical Trials Monitoring, Clinical Trials Operations, Clinical Trial Support, Conflict Management, Contract Processing, Customer Centricity, Data Analysis, Decision Making, Documentation Preparation, Document Management, Drug Regulatory Affairs, Good Clinical Practice (GCP), Growth Mindset, ICH GCP Guidelines, Independent Thinking {+ 9 more}

Preferred Skills:

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