Senior Associate, Clinical Research

Caraway Therapeutics, Inc.; Gurugram District; On-site; INR 900,000 - 1,200,000; Full time

Job summary

Caraway Therapeutics, Inc. is seeking a Senior Associate, Clinical Research to support trial and site administration across multiple regions.

You will track essential documents, update CTMS databases, manage labeling and translations, and ensure timely site start-up activities with investigators. You will handle document management, eTMF processes, budgeting and contract tracking, and assist in IRB submissions.

Qualifications

• Fluent in local languages and English with excellent communication.
• Strong knowledge of GCP guidelines and Good Documentation Practices.
• Proven ability to manage multiple tasks in a matrix multicultural environment.
• Proficient in MS Excel and general MS Office tools.

Responsibilities

• Track essential documents and report safety updates.
• Collate, distribute, ship, and archive clinical documents (eTMF).
• Update CTMS and trackers to ensure data integrity.
• Clinical and non-clinical supply management in collaboration with country roles.
• Coordinate labeling and translation change requests with country teams.
• Prepare Investigator trial file binders and translations when needed.
• Regulatory site start-up support, IRB/ERC submissions.
• Budgeting, contracts, and payments tracking; ensure compliance.
• Organize meetings and support local investigator meetings.

Skills

Fluent in local languages, English (BS

Strong communication skills

ICH-GCP knowledge

GCP/GLP awareness

Excellent negotiation skills (CTCs in/

Time management & organization

Cross-cultural collaboration

Independent problem solving

Proactive attitude

Tools

MS Excel

Job description

Job Description

Senior Associate, Clinical Research

Trial and site administration

• Track (e.g. essential documents) and report (e.g. Safety Reports)
• 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 country roles
• 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

• 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

Budgeting, Agreement and Payments

• Collaborate with finance/budgeting representatives for:
• Develop, control, update and close-out country and site budgets (including Split site budget)
• 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

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

Employee Status

Regular

Flexible Work Arrangements

Not Applicable

Job Posting End Date

10/22/2026