LinkedBio
KOREN

Job Descriptions

Job Descriptions

Explore the key roles at LinkedBio and the responsibilities each position entails.

Project Management

Clinical Project Manager

As a sponsor-side PM, you lead the full operations of clinical trials, overseeing CRO management, timeline control, budget management, and risk mitigation throughout the entire project lifecycle.

Key Responsibilities

  • Full clinical trial timeline and milestone management
  • CRO, clinical trial site, and vendor management and oversight
  • Project risk identification and mitigation planning
  • Internal sponsor reporting and stakeholder communication
  • Project budget management and resource allocation

Qualifications

  • 5+ years clinical trial PM experience
  • Phase 1–3 lead experience
  • Deep understanding of GCP and regulatory environments
Clinical Operations

Clinical Research Associate

Conduct site monitoring and data quality management for clinical trials. Handle site visits, document review, and issue resolution from the sponsor’s perspective.

Key Responsibilities

  • Clinical trial site monitoring visits (SIV, IMV, COV)
  • Source data and CRF cross-verification
  • Protocol deviation and SAE management
  • TMF/eTMF essential document management
  • Site training and communication support

Qualifications

  • 2+ years CRA experience
  • ICH-GCP training completed
  • Domestic multi-center clinical trial monitoring experience
Regulatory Affairs

Regulatory Affairs Specialist

Lead IND/NDA strategy development and regulatory document preparation. Support communication with domestic and international regulatory agencies to enhance approval readiness.

Key Responsibilities

  • IND/NDA submission strategy and timeline management
  • CTD/eCTD module writing and review
  • MFDS/FDA query response
  • Regulatory landscape monitoring and internal sharing
  • Internal training and guideline management for regulatory approvals

Qualifications

  • 3+ years RA experience
  • IND or NDA submission participation experience
  • Understanding of domestic and international regulatory frameworks
Safety & PV

Pharmacovigilance Associate

Manage the collection, evaluation, and reporting of drug safety information. Oversee safety data during development phases and fulfill regulatory reporting obligations.

Key Responsibilities

  • SAE/SUSAR case collection and evaluation
  • Periodic safety report (DSUR, PSUR) preparation support
  • Safety database management
  • Regulatory authority safety reporting obligations
  • Safety-related SOP maintenance and training

Qualifications

  • 2+ years PV or drug safety experience
  • MedDRA coding experience
  • Understanding of GVP and ICH E2 guidelines
Business

Business Development Manager

Drive company service expansion through new client acquisition and strengthening existing client relationships. Identify sponsor needs and propose tailored solutions.

Key Responsibilities

  • New business opportunity identification and lead management
  • Proposal (RFP/RFI) writing and presentations
  • Service scope and pricing negotiation
  • Existing client relationship management and expansion opportunities
  • Market trend analysis and strategy development

Qualifications

  • 5+ years pharma/bio BD experience
  • Proposal writing and client presentation skills
  • English business communication ability

Interested in a role?

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