Clinical Trials Disclosure Manager Job at Amgen (Hyderabad)

Global Clinical Trial Lead/Senior Clinical Trial Manager

As a part of the global Project Leadership group at Parexel, you are responsible...

Location

Germany

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor’s degree and minimum 6 years of relevant global trial management experience
Experience in early phase Oncology or Immunology is essential
Technical proficiency in trial management systems and MS applications, including but not limited to Teams, MS Office, Project, CTMS, EDC, IWRS/IVRS
Knowledge of ICH GCP and relevant regulatory guidelines/directives
Demonstrated interpersonal & leadership skills
Ability to understand and implement the strategic direction and guidance for respective clinical studies
Effective communication skills via verbal, written and presentation abilities

Job Responsibility

Provide leadership and direction to the trial team and is accountable for the overall success and delivery of their assigned clinical trial according to defined milestones and KPI’s
Responsible for steering and directing clinical trial activities, including patient and site engagement activities, direct communication and interaction with multiple internal and external stakeholders, and team members on a global, multi country or regional basis
Accountable for the accurate planning and operational feasibility of trial timelines
and oversight of trial preparation to ensure trial team members are aligned and on track
Supports development of trial level documents owned by other functions (e.g. Statistics, Data Management, Study Physician, Medical Writing, Site Monitoring)
Verifies and provides input into the country allocation and oversees trial feasibility
Maintains oversight during clinical trial conduct including adherence to GCP and all global and local regulatory requirements
compliance with SOPs and continuous risk monitoring/mitigation
In collaboration with other functions, ensures budget oversight, including support of regular clinical quality monitoring, SMC/DMC management and safety reporting
Prepare and implement amendments of core documents, including training material updates/retraining as needed

What we offer

Supportive work environment
High degree of empowerment and accountability
Work with a diverse set of clients and therapeutic areas
Encouraged to take on new challenges and pursue your interests
Supportive and inclusive environment
Flexible work arrangements
Varied project experience
Career progression

Site Contract Associate

Due to a growing portfolio, we are currently looking for an experienced Site Con...

Location

United Kingdom , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor's degree in a related field (e.g., law, economics, business, social sciences), equivalent training or industry experience
Proficient with Excel and PowerPoint
Excellent verbal, written and interpersonal communication skills in a dynamic and growing organization
Working knowledge of clinical trial functions, including clinical operations, regulatory and drug safety
Ability to prioritize and manage multiple tasks simultaneously

Job Responsibility

Negotiate and maintain Clinical Trials Agreements (CTA), site budgets, Confidential Disclosure Agreements, Consultant Agreements, and other applicable contracts
As required, oversee CRO or Functional Service Provider in the development of clinical site budgets and partner with clinical operations to ensure budgets are in line with study protocols
Ensures compliance of contracts with Fair Market Value (FMV) principles and guidelines
Track contract progress, complete required follow-ups and coordinate the timely completion of clinical sites contracts
Oversee CRO and Functional Service Provider activities in regards to site CDAs
Collaborate and coordinate with cross-functional teams
R&D, Legal, Compliance, Procurement and Finance in executing contracts
Develop, maintain, and analyze tools and systems (spreadsheets, Smartsheet, databases, etc.) to manage contract lifecycle from initiation through contract execution, and build internal metadata to support accurate reporting
Provide guidance and direction to new clinical operations and/or outsourcing team members and R&D teams on site contracts & budgets processes

Clinical Study Specialist

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

United States , Warren, NJ or Cambridge, MA

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Must have a Bachelor's Degree
Must have a minimum of 2 years industry related work experience
Experience supporting global trials (NA, LAM, EU, APAC, India)
Experience working in TMF, CTMS, Sharepoint
Excels in written and verbal communications
Self-starter, can work independently with minimal oversight, solution-oriented
ICF review experience
General competency: powerpoint/excel skills, meeting minutes

Job Responsibility

Organizes and delivers analyzable reports and metrics to the clinical study lead
Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings
Collates data for assessments such as feasibility and site selection and reviews site usability database
Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures
Compiles study manuals including but not limited to: study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders
Collates materials for training and investigator meetings
Tracks site activation, enrolment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan
Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings
Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance
Ensures scheduled reports are received (i.e. 1572 reportable changes, financial disclosure form)

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Contracts Manager

We are looking for an experienced Contracts Manager to join our team in Conshoho...

Location

United States , Conshohocken

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Proven experience in contract management, including drafting, reviewing, and negotiating agreements
Prior experience within the media industry preferred
Proficiency in tools such as Adobe Acrobat and Avaya CMS for document handling and communication
Strong understanding of legal terminology related to MSAs, NDAs, and other agreements
Ability to manage amendments, auditing processes, and billing functions effectively
Familiarity with advertising industry standards and practices, including banner ads and media contracts
Exceptional organizational skills and attention to detail for handling complex contractual records
Strong communication skills to liaise effectively with internal teams and external stakeholders
Knowledge of clinical trial operations and service agreements is a plus

Job Responsibility

Review and analyze Master Service Agreements (MSAs), Non-Disclosure Agreements (NDAs), and freelance contracts to ensure accuracy and compliance
Negotiate and redline contract terms with external parties to align with organizational policies and objectives
Collaborate with outside legal counsel and internal departments to address contract-related inquiries and resolve issues
Manage amendments and updates to existing agreements, ensuring proper documentation and adherence to standards
Conduct audits of contractual records and processes to maintain consistency and compliance
Oversee billing functions and administrative tasks associated with contract execution
Handle claim administration and ensure proper documentation for resolution
Support clinical trial operations by managing related service agreements and contracts
Provide guidance on advertising-related contracts, including banner ads and media placements
Maintain and utilize business systems to track and manage contractual obligations

What we offer

medical, vision, dental, and life and disability insurance
eligible to enroll in our company 401(k) plan

Clinical Outcomes Assessment Analyst

Clinical Outcome Assessment Analyst. ICON plc is a world-leading healthcare inte...

Location

United States , CARY, BLUE BELL, INDIANAPOLIS, MIAMI, TAMPA, DALLAS, HOUSTON

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Master’s degree or PhD in psychology, psychometrics, biostatistics, health outcomes, or related field
Minimum 3 years of experience in COA development, validation, and/or application in clinical research (pharma, biotech, or CRO setting)
Strong understanding of FDA and EMA guidance on COAs and patient-focused drug development
Proficiency in psychometric methods and statistical software (e.g., SAS, R, Mplus, or similar)
Excellent written and verbal communication skills with ability to summarize complex data
Strong organizational skills and ability to manage multiple projects independently
Relevant drug development and/or commercialization experience within the pharmaceutical industry with strong knowledge of patient, regulator, and payer requirements
Significant demonstrated experience in developing and implementing strategies to apply scientific methods associated with the measurement, assessment and translation of the patient experience in multiple disease areas
Knowledge of the regulatory environment with particular knowledge of FDA Patient Focused Drug Development guidance, relevant guidance from other regulatory bodies, and evidentiary standards for Clinical Outcomes Assessment (e.g. PROs, ObsROs, ClinROs, PerfOs) label claims.

Job Responsibility

Execute and ensure the effective execution of work plans resulting in the development of relevant, reliable, and timely evidence for patients, regulators, clinicians, caregivers, and payers
Design and execution of research to inform COA strategy development
Develop and execute psychometric analysis strategy
Support clinical trial development for assigned programs, including relevant portions of protocols, statistical analysis plans, study reports, briefing books, and related documents
Identify gaps in available evidence needed to support fit-for-purpose use of COAs in a specified context
As needed, design and execute research to develop or modify COA instruments for inclusion in assigned programs
Consult on COA regulatory strategy
Create and oversee the creation of scientific materials that are submitted to regulators ensuring consistent quality
Develop publications of early COA research for disclosure in peer-reviewed journals and at scientific meetings
Ensure effective packaging of information and scientific materials for patients and caregivers for dissemination and disclosure

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Parttime

Corporate Counsel/Senior Corporate Counsel, Commercial Contracts

Beam Therapeutics is seeking a highly skilled attorney to serve as the Corporate...

Location

United States , Cambridge, MA

Salary:

210000.00 - 320000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Juris Doctor (JD) from an accredited law school
admission to practice in at least one U.S. jurisdiction
5+ years of experience with complex biotechnology contracting, ideally with commercial-stage cell and gene therapy companies
Ability to manage multiple, overlapping, high-stakes agreements to completion on tight timelines
Flexible, must be able to work collaboratively with team members for a diverse range of projects
High degree of professional ethics and integrity
Sound judgement and ability to quickly analyze different sources of information
Practical and business-minded, capable of recognizing, assessing, and responding to urgent matters with timely, pragmatic, and clear solutions
Exceptional and demonstrated written and verbal communication skills
Candidates are expected to come onsite 2 days per week

Job Responsibility

Draft and negotiate high-stakes agreements in support of Beam’s anticipated product launches, including complex commercial contracts with gene therapy treatment centers, channel partners and manufacturers
Assist with legal review of other pre-commercial activities, including advisory boards, patient engagement events, patient support programs, market access activities, speaker programs, and market research
Provide legal support to Beam’s various promotional material review committees
Provide ongoing contracting support and lifecycle management, including agreement interpretation and risk analysis, for Beam’s commercial, medical affairs, manufacturing and other teams
Collaborate with business teams and subject matter experts on continuous review and updates of Beam contracting playbooks and standards
Draft and negotiate a range of other key agreements in support of Beam’s broader business, including clinical trial agreements, material transfer agreements, sponsored research agreements, service provider agreements, and non-disclosure agreements

Fulltime

New

Senior Product Manager

The Senior Product Manager, Platform, is a strategic, cross-functional leader re...

Location

Salary:

Not provided

LoadUp

Expiration Date

Until further notice

Requirements

5+ years in Product Management
at least 2 years specifically focused on platform, infrastructure, or technical products
Deep understanding of APIs, microservices, and data pipelines
Proficiency with tools like Looker, Amplitude, or Mixpanel to drive data-informed decisions
Expert at writing User Stories and managing roadmaps in a high-speed, growth-oriented environment
Experience with on-demand platforms or complex marketplaces is strongly preferred

Job Responsibility

Roadmap Ownership: Define and manage the platform roadmap
Technical Discovery: Lead research to understand needs and translate them into product specs
Build/Buy/Partner: Collaborate with Architecture leads on scalable solutions
Sprint Leadership: Serve as primary stakeholder in sprint planning
Performance Tracking: Define and monitor key platform metrics
Cross-Functional Champion: Represent the platform team in executive reviews

What we offer

401(k) with 5% Company Match
Comprehensive Benefits – Medical, Dental, Vision, Life, FSA, and HSA options
Monthly Lifestyle Stipends

New

Event Producer

This is a unique opportunity to join a global events leader and make your mark i...

Location

South Korea

Salary:

Not provided

Encore Global

Expiration Date

Until further notice

Requirements

Sales-first mindset – proven ability to prospect, pitch, and secure event business
Event production expertise – strong understanding of AV, staging, lighting, creative, and event operations
End-to-end delivery skills – experience running events from concept through to onsite execution
Relationship builder – excellent communication and client-facing skills
ability to become a trusted advisor
South Korea market knowledge – connections in corporate, government, or association sectors highly valued
Proactive and self-motivated – thrives in a fast-paced environment, managing multiple projects and deadlines
Global mindset – eager to tap into Encore’s international network, training, and career pathways for long-term growth
Cultural fit – embodies Encore’s “Creating Unforgettable” ethos with energy, creativity, collaboration, and resilience

Job Responsibility

Proactively prospect, pitch, and secure new event opportunities across various industries
Lead the end-to-end event lifecycle — from initial enquiry, proposal, and design through to onsite execution
Translate client briefs into tailored AV, staging, and creative production solutions aligned to needs and budgets
Collaborate closely with Encore’s technical and creative teams to ensure flawless delivery
Provide hands-on producer leadership onsite, ensuring events are executed to the highest standards
Manage budgets, timelines, and resources to achieve both client satisfaction and commercial outcomes
Build and maintain long-term client relationships, becoming a trusted advisor for future events
Achieve monthly sales targets and pipeline KPIs while consistently delivering impactful client experiences
Contribute to Encore’s culture of “Creating Unforgettable” by bringing innovation, energy, and collaboration to every event

What we offer

Diversity, equity, and inclusion programs that foster a welcoming and inclusive workplace for all
Wellness initiatives to prioritise your physical and mental well-being
Ample opportunities for career progression and professional growth
Commitment to sustainability initiatives, contributing to a greener future
Salary packaging options

Fulltime

Clinical Trials Disclosure Manager

Amgen

Location:
India , Hyderabad

Category:
-

Contract Type:
Not provided

Salary:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
February 13, 2026

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