Clinical Research Manager

Clinical Research Manager

Location:

Role Purpose

cost-effective, inspection-ready

Key Responsibilities

1) Study Strategy & Planning

• Translate program needs (e.g., bioequivalence for ANDA filings; Phase IV/PMS objectives) into clinical development and study plans with clear

  endpoints, timelines, and budgets

  .
• Lead protocol design/review (including ICF, statistical assumptions, PK sampling schedules, crossover/washout for BE).
• Define country/site strategy (India focus with ROW options), site feasibility, patient population, and risk-based monitoring (RBM/RBQM) plans.
• Build study budgets and resource plans; present business cases to leadership.

2) Execution & Oversight (Sponsor Responsibilities)

• Select and manage CROs, BA/BE centers, central labs, IRT/RTSM, bioanalytical & statistical vendors; negotiate scope and SLAs.
• Oversee

  start-up to close-out

  : EC/IRB & CTRI submissions, SIV/IMV, IP management, enrollment, data cleaning, database lock, and CSR.
• Ensure

  eTMF completeness

  , timely TMF QC, and CTMS/EDC data integrity (21 CFR Part 11–compliant systems).
• Review and approve monitoring reports, protocol deviation/violation logs, and data-review listings; drive CAPAs to closure.

3) Quality, Compliance & Inspection Readiness

• Ensure full compliance with

  ICH-GCP E6(R2/R3)

  ,

  NDCT 2019

  , CDSCO guidance, and BDR SOPs.
• Partner with QA for

  vendor and site audits

  ; lead CAPA design and effectiveness checks.
• Maintain inspection-ready documentation; coordinate responses during CDSCO/DCGI, USFDA BIMO, or EMA inspections.
• Ensure SAE/SUSAR reporting compliance and PV handshakes (PvPI/Global Safety).

4) Data, Biostatistics & Bioanalytics

• Oversee statistical analysis plans (SAP), PK/PD modeling (NCA), randomization schedules, and sample size justifications.
• Supervise bioanalytical method validation/transfer and sample logistics; ensure GLP compliance at partner labs.
• Own the

  data review/cleaning strategy

  , data reconciliation (safety/central lab), and on-time

  CSR

  delivery.

5) Regulatory & Ethics Interface

• Lead/coordinate interactions with

  CDSCO/SEC

  , Ethics Committees, CTRI registration, and respond to regulatory queries supporting

  ANDA/NDA/dossier

  filings.
• Provide clinical content for submissions (protocols, CSRs, BE summaries, clinical overviews) and support labeling/SmPC updates.

6) Stakeholder Leadership & People

• Coach a matrix team (internal CRAs/CTAs/Study Leads) and manage CRO performance; drive vendor scorecards and governance.
• Partner with

  Regulatory, QA, PV, CMC, Supply Chain, and Medical

  to assure integrated program delivery.
• Build internal capability via training on GCP, protocol conduct, and inspection readiness.

7) Governance, Risk & Budget

• Run study governance (Steering/Operating Committees), risk registers, and mitigation plans.
• Control study budgets with

  10% variance

  ; manage change orders; track milestones and cash-flow.

Candidate Profile

Must-have

• 10+ years

  across sponsor/CRO/BA-BE settings with

  hands-on ownership of BE studies

  (design to CSR) and exposure to

  Phase IV/PMS

  .
• Proven

  CRO/BA-BE vendor management

  , site/start-up oversight, and inspection readiness experience (CDSCO; exposure to USFDA/EMA is a plus).
• Strong command of

  ICH-GCP, NDCT 2019, CDSCO

  processes, ethics/CTRI, SAE/SUSAR reporting, and TMF/EDC/CTMS ways of working.
• Working knowledge of

  PK/PD fundamentals

  , statistics/SAP review, and bioanalytics (method validation, sample handling).
• Excellent documentation, problem-solving, and cross-functional leadership skills.

Good-to-have

• Therapeutic exposure in

  Oncology/Injectables/OSD

  ; experience supporting

  ANDA

  or global dossiers.
• Familiarity with

  WinNonlin

  , MedDRA, EDC (e.g., Medidata Rave/Oracle InForm),

  eTMF

  (e.g., Veeva Vault),

  CTMS

  , and

  IRT/RTSM

  .
• Prior participation in

  regulatory inspections

  (CDSCO/USFDA BIMO/EMA) and responding to observations.

Behavioral Competencies

• Ownership & accountability, vendor negotiation, stakeholder management, analytical thinking, urgency with quality, and clear executive communication.

Travel: