Informed consent forms jobs

Country Approval Specialist

Thermo Fisher Scientific · Posted Jun 23, 2026

Open

Beijing, China
On-site
Full-time · Associate
2+ years

Country Approval Specialist

Thermo Fisher Scientific · Posted Jun 23, 2026

Open

Beijing, China
On-site
Full-time · Associate
2+ years

Medical Director/Clinical Trial Physician

Thermo Fisher Scientific · Posted Jun 5, 2026

Open

Remote, United States
Remote
Full-time

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Lead medical oversight for clinical trials, develop protocols, ensure regulatory compliance, and collaborate with cross‑functional teams.

Compensation

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.

Responsibilities

Provide medical leadership to study teams
Create and review clinical trial protocols and amendments
Ensure medical validity of primary endpoints
Interpret clinical trial data for regulatory documents
Serve as medical point of contact for investigators and stakeholders

Requirements

Medical Doctor
Board certification in rheumatology
Nice to have: 1-3 years industry experience in clinical development
Nice to have: Pharmaceutical/Biotech/CRO experience

Skills

clinical trial protocols GCP NDA submission regulatory guidelines clinical study reports informed consent forms

Sr Staff Clinical Technical Program Manager, APAC

Dexcom · Posted Nov 6, 2026

Open

Sydney, New South Wales, Australia
Hybrid
Full-time · Senior
13+ years

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Lead planning and execution of complex clinical programs across the Asia Pacific region, driving multi-country studies and collaborating with global stakeholders.

Responsibilities

Lead the full lifecycle of clinical studies from protocol design to closeout
Manage study operations, timelines, budgets, and performance metrics
Coordinate and prioritize activities across multiple studies
Identify and mitigate risks related to study implementation
Drive selection, onboarding, and management of CROs and external vendors

Requirements

Bachelor’s degree in a technical discipline
Master’s degree with 8+ years equivalent industry experience
PhD with 5+ years of experience
Nice to have: experience managing external CROs
Nice to have: supporting diabetes or digital health studies

Skills

clinical research regulations Good Clinical Practice (GCP) requirements clinical study management protocol design Informed Consent Forms (ICFs)

Sr Staff Clinical Technical Program Manager, APAC

Dexcom · Posted Nov 6, 2026

Open

Sydney, New South Wales, Australia
Hybrid
Full-time · Senior
13+ years

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Lead planning and execution of complex clinical programs across the Asia Pacific region, driving multi‑country studies and collaborating with global stakeholders.

Responsibilities

Lead planning and execution of complex clinical programs across APAC
Provide strategic direction and leadership to clinical study teams
Partner with cross‑functional core teams and external CROs
Develop and implement clinical study strategies
Manage study operations, timelines, budgets, and performance metrics

Requirements

Bachelor’s degree in a technical discipline
Master’s degree with 8+ years equivalent industry experience
PhD with 5+ years experience
Nice to have: experience managing external CROs for Class II and Class III medical device studies
Nice to have: experience supporting diabetes or digital health studies

Skills

clinical research regulations Good Clinical Practice (GCP)medical device industry experience project management budget management

Freelance Quality Controllers (Korean)

IQVIA Language Solutions · Posted Oct 29, 2026

Open

Remote
Remote
Contract

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Quality Controller responsible for post-linguistic and formatting quality control of medical translation content.

Responsibilities

Verify completeness and accuracy of translated documents
Ensure target file formatting matches source
Implement tracked changes correctly
Check language accuracy for critical elements
Review headers, footers, tables of contents, and links

Requirements

Nice to have: translation quality control
Nice to have: linguistic services
Nice to have: quality assurance processes
Nice to have: knowledge of language scripts

Skills

multilingual quality control English Korean Microsoft Word Track Changes attention to detail independent work medical content review

Senior Clinical Study Manager

Intuitive · Posted Nov 5, 2026

Open

Sunnyvale, California, United States
Senior
5+ years

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Lead and manage clinical and outcomes research studies to support regulatory approvals and strategic evidence initiatives.

Responsibilities

Develop and execute strategies for clinical and outcomes research studies
Design and develop clinical protocols and study documents
Lead site selection, initiation, monitoring, and close-out visits
Ensure compliance with GCP and regulatory requirements
Collaborate with CRAs, CTAs, biostatisticians, and external vendors

Requirements

Advanced degree in a scientific or bioengineering field (M.S., Ph.D., or M.D.) with minimum 5+ years of clinical research experience
Bachelor's degree in a scientific or bioengineering field with minimum 8+ years of clinical research experience
Minimum of 10+ years of clinical research experience combined with relevant scientific or technical training
Nice to have: Hospital environment experience
Nice to have: Statistical methods and design of experiment

Skills

Clinical study management Protocol and ICF development Literature search and appraisal

Medical Director, Clinical Sciences

Regeneron Pharmaceuticals · Posted Nov 4, 2026

Open

Tokyo, Tokyo, Japan
Hybrid
Full-time · Senior
5+ years

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Lead clinical development programs in Japan, supporting global teams and ensuring compliance with Japanese regulatory requirements.

Responsibilities

Support the Japan Clinical Development Lead in clinical components of assigned development programs
Adapt clinical trial protocols, amendments, CRFs, IRB applications, informed consent forms, and recruitment materials for Japan-specific requirements
Provide clinical input for regulatory documents including CTN submissions, Investigator Brochures, J-NDA/J-CTD submissions, and PMDA responses
Review clinical data and prepare study reports, abstracts, manuscripts, and presentations
Assess clinical feasibility with local medical needs for Japan's participation in global studies and provide enrollment input

Requirements

MD
MD/PhD

Skills

clinical trial design protocol design clinical data review medical monitoring regulatory filings

Research Specialist - Regulatory/Compliance

UPMC · Posted Nov 5, 2026

Open

Pittsburgh, Pennsylvania, United States
Hybrid
Full-time · Associate

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The role focuses on pre-award activation of industry-sponsored clinical trials by preparing and managing regulatory documentation required for initial approvals and ongoing compliance and integrity.

Responsibilities

Prepare and review pre-award regulatory documents, namely informed consent forms (ICF), in compliance with UPMC policies/language, sponsor requirements, and 21 CFR Parts 50, 54, 56, 312, 812, 45 CFR 46, and ICH-GCP E6.
Conduct and lead institutional review and negotiation of ICF language with industry sponsors for new protocol study submission and study amendments.
Guide study teams to properly submit approved ICFs to Institutional Review Boards (IRBs) in accordance with 21 CFR Part 56 and institutional procedures.
Provide guidance to study teams by reviewing and approving regulatory materials for Expanded Access and Compassionate Use studies (sINDs, HUDs, EAPs, etc.), ensuring compliance with 21 CFR 312 and FDA guidance, while supporting timely activation.
Maintain accurate submission records and tracking systems to support pre-award decision-making, study startup timelines, and study activation metrics.

Skills

Regulatory documentation management Informed consent forms (ICF)21 CFR regulations

Medical Affairs Associate

Gilead Sciences · Posted Nov 2, 2026

Open

Remote, United States
Remote
Contract · Associate
3–5 years

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Supports Medical Affairs activities related to expanded access programs, out-of-specification case support, and single-patient IND processes.

Responsibilities

Assists and manages clinical trials from startup to closure
Reviews study-related documents
Manages assigned components of studies or expanded access activities
Supports out-of-specification programs and expanded access programs
Manages vendors and contract research organizations

Requirements

BS/BA/RN in nursing, science, or a health-related field
Nice to have: oncology
Nice to have: hematology
Nice to have: cellular therapy
Nice to have: iMedidata/RAVE EDC

Skills

clinical trials CTMS eDC RDMS clinical protocols informed consent forms investigator brochures

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