Manager, Biospecimen Data Operations Job at Amgen (Hyderabad)

New

Biospecimen Data Operations Specialist

Accountable for accurate and compliant study configuration in LIMS (products, ca...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree & 3 years of experience with a strong Knowledge of clinical trials
Bachelor’s degree & 5 years of experience with a strong Knowledge of clinical trials
Prior experience in biospecimen operations and management in relation to clinical trials
Advanced LIMS configuration and system navigation skills
Strong understanding of specimen logistics, assay workflows, and lab interfaces
Technical fluency in file imports, mapping tables, template logic, and interface parameters
Precision documentation and audit-trail discipline
Structured troubleshooting across imports, shipments, and transfer failures
Knowledge of blinding controls and unblinding data handling
Multi-study prioritization and deadline management

Job Responsibility

Accountable for accurate and compliant study configuration in LIMS (products, categories, test plans, cohorts, schedules)
Accountable for corresponding system configurations, dose schema alignment, and blinded data safeguards
Accountable for clinical data management interface setup, template selection, mapping integrity, and transfer readiness
Accountable for TrialBridge imports, quarantined record review, and discrepancy release
Accountable for inventory files and external biorepository interface initiation, monitoring, and shipment registration validation
Accountable for work order/test order creation and export template governance
Accountable for BSM Plan generation, version control, and DARS readiness inputs
Accountable for shipment readiness controls (no discrepant samples shipped)
Accountable for study status transitions (Approved/Active/Completed) and end-of-study system closure
Accountable for documentation completeness across study lifecycle (data flow maps, contact lists, study-level logs)

Senior Manager, Clinical Biomarker Operations

The Department of Research and Translational Medicine is seeking a Sr. Manager, ...

Location

United States , Boston

Salary:

160000.00 - 175000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

MS or higher with > 3 years or BS with >5 years of direct experience in biomarker operations role
Demonstrated experience with biomarker sample management, including sample logistics, reconciliation, and inventory maintenance from sample collection to long-term storage
Significant experience with CRO oversight, including contract management, SOW reviews, activity and accrual tracking, and final reconciliation of activities
Experienced in all phases of clinical trials, Phase 3 experience is an asset
Good understanding of biomarker assays, including flow cytometry, genomics, protein-based assays, and drug development in general
High level of emotional intelligence and able to collaborate effectively as a member of cross-functional teams, excellent communication skills to drive projects and manage timelines
Experience in I&I indications
Enjoys fast paced environment, flexible, able to manage multiple and competing priorities under tight timelines
Successfully exhibits Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
Ability and willingness to travel, including a minimum of ~4 times per year for All Hands meetings and other workshops

Job Responsibility

Plan, track, and manage logistics around biomarker sample collection across all our clinical trials, oversee sample shipments and testing at vendors, undertake sample reconciliation as needed, plan and inform teams on data delivery timelines, and manage final sample disposition
Ensure adherence to the clinical study protocol, contribute to biospecimen collection guidelines in protocols, ICFs, and lab manuals, and lead finalization of data transfer specifications
Maintain sample inventories, coordinate sample collection, and manage short-term and long-term sample storage solutions
Work in close collaboration with relevant stakeholders including Biomarker Scientists, Data Management, Clinical Operations, Legal, Finance, Procurement, and Quality Assurance
Support and coordinate review and finalization of MSAs, legal agreements, and other contracts related to clinical biomarker activities, labs, and partnerships
Support QA in vendor audit and inspection activities
Support activities related to biomarker budget planning and tracking of accruals
Lead vendor selection, performance management, and vendor oversight to ensure compliance with Apogee standards
Continuously identify and build best practices for process improvements
Ensure high quality data generation by overseeing sample integrity and external collaborations

What we offer

A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

New

Associate Operations Manager, Translational Medicine

The Translational Medicine Group (TMG) supports the clinical development of Caba...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

BS in a biological sciences or biomedical engineering-related field with 3+ years of experience in clinical drug development or an equivalent combination of education and experience
Experience in reviewing clinical protocol-associated documents including informed consent forms (ICFs) is highly preferred
Experience with clinical sample handling and inventory management is highly preferred
Knowledge of requirements for biospecimen acquisition to support downstream analyses (i.e., flow cytometry, immunoassays, PCR, NGS)
Highly organized, with the capacity to prioritize and provide consistent, timely responses working both collaboratively and independently
Strong communication skills required to interact effectively with internal and external stakeholders, senior management, and external CROs
Management of contract research organizations is preferred
Previous exposure to translational science operations in the cell therapy field, including biospecimen sample processing and handling, is advantageous
Strong team orientation and passion for continuous self-development
Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities

Job Responsibility

Work closely with the Operations Manager, Translational Medicine on the management and handling of clinical samples, both internally and externally, including supporting the shipping and receiving of clinical samples
Sample quality oversight: Including surveying data sources for TMG sample collection, processing and transit issues. Record sample deviations, manage and track implementation of CAPAs where applicable, in collaboration with Central Lab vendor(s) and the Quality team
Vendor Oversight: review invoices, evaluate vendor performance, build relationships with vendors and courier services
Reconcile informed consent for the use of clinical biospecimens to support translational scientists and external partners
Support on-site sample receiving and verification upon sample arrival
Coordinate timely shipments of clinical samples from central labs to testing labs/CROs and to our in-house lab team
Manage concurrent timelines for multiple internal projects
Review relevant sections of clinical study related documents
Support inventory buildout and testing workflows in TMG’s Laboratory Information Management System(s) (LIMS)
Assist in timely review of CRO research contracts and invoices through communication with legal and finance groups respectively

What we offer

health and retirement, PTO, and stock option plans

New

Manager, Biospecimen Reporting and Automation

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
OR Master’s degree & 3 years of experience in supplier management at sponsor or supplier leadership at the vendor
OR Bachelor’s degree & 5 years of experience in supplier management at sponsor or supplier leadership at the vendor
OR Associate’s degree and 10 years of experience in supplier management at sponsor or supplier leadership at the vendor
Strong project management experience
Fluency in English, both in written and oral communication
Excellent user of Office Programs such as Excel, Word, Power point
Scientific or drug development technical expertise supporting Research, Development, Medical, Global Regulatory, Global Safety or Knowledge Management

Job Responsibility

Define and maintain standards for automated reporting, dashboards, and validation practices
Oversee development and maintenance of Appendix I reports and other regulated analytics deliverables
Review and approve dashboards, scripts, and reporting templates prior to production release
Ensure compliance with data governance, validation logic, and version control requirements
Serve as escalation point for complex automation failures, data discrepancies, or reporting risks
Partner with Data Management, Clinical Operations, IT, and Quality to align analytics outputs with business and regulatory needs
Deliver or oversee delivery of monthly KPI and performance summaries to R&D Ops leadership
Drive continuous improvement by identifying opportunities to expand automation and reduce manual reporting burden
Support inspection readiness by ensuring documentation, validation, and traceability of analytics tools
Accountable for creation of automation and maintenance of standard reporting suite

What we offer

Reasonable accommodation for individuals with disabilities

New

Biospecimen Quality and Reconciliation Specialist

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree & 3 years of experience with a strong Knowledge of clinical trials
Bachelor’s degree & 5 years of experience with a strong Knowledge of clinical trials
Prior experience in biospecimen operations and management in relation to clinical trials
Strong reconciliation and cross-system validation logic
Root cause analysis capability across vendor, site, and system issues
Knowledge of data base lock processes and regulatory documentation standards
High-detail orientation with investigative rigor
Understanding of consent-based restrictions and disposition workflows
Ability to operate independently as quality control layer
Risk sensitivity regarding blinded data and final transfer integrity

Job Responsibility

Accountable for cross-system reconciliation
Accountable for discrepancy queue management and pre-shipment resolution
Accountable for validation of results imports (automated and manual) including second-person verification controls
Accountable for data management interface validation prior to exports
Accountable for final results completeness verification and samples-not-resulted reporting
Accountable for database lock reconciliation and evidence package preparation
Accountable for Sample Data Change reporting cadence and Vendor Issue Log review
Accountable for disposition governance (withdrawals, consent not obtained, compromised samples)
Accountable for end-of-study operational checks and archive-ready documentation
Accountable for identifying systemic discrepancy trends and recommending corrective actions

Senior Clinical Research Operations Associate, Oncology

We are seeking a detail-oriented Senior Clinical Research Operations Associate t...

Location

United States , Menlo Park

Salary:

84480.00 - 95041.00 USD / Year

BillionToOne

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a life science, public health, or related field with 2–3 years of hands-on clinical research coordination or clinical operations experience, or a Master’s degree (MPH or related) with 1–2 years of relevant clinical research experience
Working knowledge of IRB processes, informed consent, and Good Clinical Practice (GCP), with experience supporting submissions and ongoing study maintenance
Hands-on experience with clinical research database management (e.g., REDCap), including database build or maintenance, data entry oversight, and routine data quality review
Basic proficiency in SQL, and R or python for clinical data handling, including data cleaning, simple summaries, and generation of tables or figures for internal use
Strong organizational, communication, and project management skills, with the ability to manage multiple concurrent tasks, work collaboratively in a cross-functional environment, and execute independently under direction

Job Responsibility

Manage day-to-day operations for oncology clinical studies, including study timelines, task tracking, cross-functional coordination, study start-up and close-out activities, and preparation of internal status reports and study materials
Support regulatory and IRB activities under supervision, including preparation and submission of IRB applications, amendments, continuing reviews, protocol deviations, and maintenance of regulatory documentation in compliance with GCP
Develop, maintain, and monitor REDCap databases, including database build aligned to study protocols, routine data quality review, discrepancy tracking, and follow-up with study teams to ensure clean, analysis-ready datasets
Coordinate biospecimen, laboratory, and biobanking operations, including sample collection, shipment, accessioning, tracking, and collaboration with laboratory teams to build, curate, and maintain oncology specimen biobanking procedures and databases
Provide operational and analytical support for clinical data and scientific outputs, including preliminary data review, literature summaries, and assistance with internal analyses and development of scientific materials for presentations or publications

What we offer

Working alongside brilliant, kind, passionate and dedicated colleagues, in an empowering environment, toward a global vision, striving for a future in which transformative molecular diagnostics can help millions of patients
Open, transparent culture that includes weekly Town Hall meetings
The ability to indirectly or directly change the lives of hundreds of thousands patients
Multiple medical benefit options
employee premiums paid 100% of select plans, dependents covered up to 80%
Extremely generous Family Bonding Leave for new parents (16 weeks, paid at 100%)
Supplemental fertility benefits coverage
Retirement savings program including a 4% Company match
Increase paid time off with increased tenure
Latest and greatest hardware (laptop, lab equipment, facilities)

Fulltime

New

Clinical Research Coordinator

The Ebrahimi-Fakhari Laboratory within the Movement Disorders Program in the Dep...

Location

United States , Boston

Salary:

44657.60 - 69773.60 USD / Year

Boston Children's Hospital

Expiration Date

Until further notice

Requirements

Bachelor’s degree in neuroscience, biology, biochemistry, public health, psychology, or a related discipline required
Two years of related work experience is required for the role
Strong organizational and communication skills with attention to detail and the ability to manage multiple responsibilities in a fast-paced research environment
Experience coordinating human subject research studies or working in a clinical research environment is preferred
Familiarity with research databases (e.g., REDCap), regulatory documentation, and IRB processes is desirable
Experience working with patient populations, rare diseases, or neurological disorders is beneficial

Job Responsibility

Coordinate daily operations of clinical research studies, including scheduling and conducting study visits
Recruit and consent research participants and assist with participant screening and enrollment
Collect and manage clinical data, patient-reported outcomes, and biospecimens
Maintain accurate study documentation and regulatory binders in accordance with Good Clinical Practice (GCP) standards
Assist with Institutional Review Board (IRB) submissions, amendments, and continuing reviews
Maintain research databases (e.g., REDCap) and ensure data quality and completeness
Track study milestones, enrollment metrics, and research activities
Coordinate shipping, tracking, and documentation of research samples when applicable
Assist with coordination of multi-site research collaborations and communication with study partners
Support preparation of study materials, abstracts, reports, and progress updates for funding agencies

What we offer

flexible schedules
affordable health, vision and dental insurance
child care and student loan subsidies
generous levels of time off
403(b) Retirement Savings plan
Pension
Tuition and certain License and Certification Reimbursement
cell phone plan discounts
discounted rates on T-passes

Fulltime

Research Coordinator – Oncology Clinical Trials

Performs clinical and administrative coordination of sponsored clinical trials, ...

Location

United States

Salary:

30.70 - 46.05 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

Typically requires 2 years of experience in Research
Knowledge of Good Clinical Practices, International Conference of Harmonization, FDA Guidance documents, Department of Health and Human Services regulations, standard operating procedures
Ability to successfully conduct and manage a research study
Ability to mentor team members and to prepare training plans
Excellent verbal and written communication skills, organizational and time management skills with ability to work under pressure and meet deadlines
Ability to problem solve and work independently with a high degree of accuracy and attention to detail
Must be able to establish a good rapport with patients, investigators and sponsors
Competency in using Electronic Medical Record (EMR), Microsoft Office Suite, and other computerized programs
Must be able to sit, stand, walk, lift, squat, bend, reach above shoulders and twist throughout shift
Must have functional sight and hearing

Job Responsibility

Performs clinical and administrative coordination of sponsored clinical trials, research protocols/projects, and biospecimen collection studies, as applicable
Provides guidance to physicians, clinical staff and research team members
Coordinates assigned research studies in collaboration with other team members and key stakeholders, including but not limited to
study start-up, review of study CTA/budget/CTMS, IRB submissions, recruitment, screening, and enrollment of research subjects, development of mechanisms to maximize subject adherence to the research protocol, maintain source documentation, data collection (i.e. development, completion and submission of case report forms (EDC), study drug/device accountability, monitoring of subjects, AE/SAE reporting, study close out, and facilitates quality assurance inspections and audits
Acts as a liaison between sponsor and investigators and as the primary protocol/project contact for team members and clinical staff
Plans, develops and implements educational plans to disseminate protocol/project information with research staff, investigators and clinical staff
Reviews protocol amendments and updates, research related orders (in collaboration with Investigational Drug Services), and study-specific workflows
Ensures that laboratory requirements are being met for specimen procurement, proper collection, processing and shipment of specimens
Serves as Primary Research Coordinator on studies across multiple sites guiding research team members involved in the study and coordinates and tracks research activities across sites
Coaches and mentors research team members and other personnel

What we offer

Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program

Fulltime

Manager, Biospecimen Data Operations

Amgen

Location:
India , Hyderabad

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
March 19, 2026

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for Manager, Biospecimen Data Operations

Biospecimen Data Operations Specialist

Senior Manager, Clinical Biomarker Operations

Associate Operations Manager, Translational Medicine

Manager, Biospecimen Reporting and Automation

Biospecimen Quality and Reconciliation Specialist

Senior Clinical Research Operations Associate, Oncology

Clinical Research Coordinator

Research Coordinator – Oncology Clinical Trials

Manager, Biospecimen Data Operations

Amgen

Location:India , Hyderabad

Category:Research and Development

Contract Type:Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:March 19, 2026

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for Manager, Biospecimen Data Operations

Biospecimen Data Operations Specialist

Senior Manager, Clinical Biomarker Operations

Associate Operations Manager, Translational Medicine

Manager, Biospecimen Reporting and Automation

Biospecimen Quality and Reconciliation Specialist

Senior Clinical Research Operations Associate, Oncology

Clinical Research Coordinator

Research Coordinator – Oncology Clinical Trials

Location:
India , Hyderabad

Category:
Research and Development

Contract Type:
Not provided

Job Posted:
March 19, 2026