Clinical Laboratory Study Manager Job at Parexel

Clinical Laboratory Study Manager

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Minimum of 6 years clinical research experience with academic, Contract Research Organization, pharmaceutical or biotech industry
Working knowledge of clinical drug development process and clinical databases, as well as ICH, GCP guidelines, and US FDA and/or local country regulations as applicable
Requires bachelor degree in life sciences or equivalent (i.e., science, technology, engineering, or mathematics) or relevant work experience. Biology or equivalent major preferred.
Strong project management and organization skills in a matrix environment
Analytical and problem-solving experience
Excellent written and verbal communication skills
Effective communication and interpersonal skills, with proven ability to build relationships internally and externally
Fluent in speaking/writing English
Proficiency in Microsoft Office applications, including strong excel knowledge, as well as relevant role specific systems
Proficiency in Python, R, Perl, SQL or other programming languages, as well as familiarity with APIs and Linux/Unix environments, if acting as programming lead for supplies and laboratory operations

Job Responsibility

Participates in cross-functional study team meetings and workstreams to support the delivery of the precision medicine strategy for the assigned studies
Supports clinical study teams as subject-matter expert for technical and operational matters related to sample management and testing, including anticipating challenges, managing risk across projects and responding queries from internal and external stakeholders
Works with clinical study teams on the development and review of sample-related sections of study-specific documents such as the clinical protocol, Informed Consent Forms (ICFs) and sample management guidelines
Supports project management and study set-up teams in the creation and validation of specialty laboratory databases for data collection and sample kit tracking
Manages all activities related to biosample process planning and execution, including storage, shipping, and data transfer throughout the study lifecycle
Oversees the acquisition and testing of clinical trial samples designated for biomarker research (including human tissue, whole blood, plasma, serum, etc.), liaising with relevant stakeholders to assess biosample vendors, review proposals/bids, and define contractual scope
Forecasts operational costs and timelines, and manages budgeting, invoicing and reporting for study-related operations
Works closely with data management and biostatistics leads to determine how biomarker data will be captured, blinded, transferred and reported for clinical trials
Develops and reviews data transfer specifications and related documents
Provides guidance and training to clinical teams and investigative sites regarding collection, storage and shipment of biospecimens to ensure compliance with the clinical protocol

Clinical Trial Manager/ Sr Clinical Trial Manager (PM/ Sr PM)

Clinical Operations Lead - Early Development Oncology. ICON plc is a world-leadi...

Location

United States , Raleigh, Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

BS/BA degree or a relevant degree with strong emphasis on science, or equivalent experience
Minimum of five years of relevant experience in the biopharmaceutical industry or other relevant clinical research experience, with a focus on skills and competencies
Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health
Prior experience in assisting the conduct and management of multinational clinical trials is preferred
Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously
Experience in oncology studies required (phase I preferred)

Job Responsibility

Participate as a member of a working group and perform special projects, as assigned, to improve the efficiency, effective and quality of the functioning of the Development Operations department
Act as preliminary liaison for study sites to convey study information, answer questions and in accordance with the escalation pathway
Develop relationships with investigational sites, HCPs, and institutions to enhance conduct of the trial
Monitor study-specific timelines and key deliverables
focus on management of all relevant external vendors (e.g., Monitoring, Sample management, IVRS, Laboratory, etc)
Participate as a member of the multi-disciplinary trial(s) team
Participate in coordinating efforts with internal Pharmacovigilance, and safety group as needed
Participate in data review and discrepancy resolution as needed
Assist in the development of the IP and co-medication strategy (quantities, labels, depots, tracking, etc.) working closely with other departments
Plan and organize meetings with team support (e.g., investigator/coordinator meetings, DMC, SMC, safety call, etc.) as appropriate

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

Clinical Study Specialist

Clinical Study Specialist ICON plc is a world-leading healthcare intelligence a...

Location

United States , Basking Ridge

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
Vendor management/oversight experience a plus
Must be open to hybrid office/home based in Warren NJ, Armonk NY or Cambridge MA

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

Fulltime

Clinical Study Specialist

Clinical Study Specialist (office based). ICON plc is a world-leading healthcare...

Location

United States , Boston; Basking Ridge, NJ

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
Vendor management/oversight experience a plus
Must be open to hybrid office/home based in Warren NJ, Armonk NY or Cambridge MA

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

Fulltime

Senior Manager Clinical Operations and Strategic Alliances

The Sr. Manager, Clinical Operations and Strategic Alliances reporting to the Di...

Location

United States , Pleasanton

Salary:

173100.00 - 234100.00 USD / Year

10x Genomics

Expiration Date

Until further notice

Requirements

An Advanced degree (M.S., PharmD, Ph.D., M.B.A.) in a Life Science, Clinical, or related field is required
8+ years of relevant industry experience with 4-5 years of experience in Clinical Operations and Alliance / Program Management within the diagnostics, biotechnology, or pharmaceutical industry
Direct experience managing research studies involving large numbers of patient samples and complex molecular testing or biomarkers
Deep understanding of clinical study execution, site management, and the complexities of clinical sample logistics and chain of custody
Direct experience in managing high-value strategic alliances and driving value through the successful execution of collaborative research, development, or commercialization agreements
Demonstrated ability to manage competing priorities, swiftly resolve complex operational problems, and drive tangible results

Job Responsibility

Study Execution: Manage the operational execution of large-scale, longitudinal clinical research studies according to established agreements with academic institutions
Timeline & Risk Management: Own and drive clinical research study timelines, deliverables, and operational plans ensuring adherence to sampling schedules
identify operational risks regarding enrollment, setup, or logistics early, implementing mitigation strategies to maintain study integrity
Sample Logistics & Chain of Custody: Establish and enforce auditable procedures for sample collection, tracking, and chain of custody, ensuring compliant transport from clinical sites to 10x Genomics laboratory
Budget & Resource Oversight: Manage the study budgets, including the oversight of reimbursement, equipment provisioning, and consumables provided to partner sites
Regulatory & Quality Compliance: Ensure all study activities comply with IRB protocols, patient consent requirements, and GCLP/CLIA standards where applicable
Partnership Management: Manage a diverse, high-value portfolio of academic collaborations and strategic partnerships to ensure all projects and agreements track toward established milestones and outcomes
Governance Management: Ensure transparent communication, effective decision-making, and rapid conflict resolution between internal teams and external partners
lead and facilitate Joint Steering Committees (JSCs) and cross-functional governance meetings as needed
Stakeholder Management: Act as the primary liaison between internal teams and key stakeholders at relevant academic institutions and industry partners to foster strong, collaborative relationships that drive engagement and performance

What we offer

Equity grants
Comprehensive health and retirement benefit programs
Annual bonus program or sales incentive program
Generous time off
Competitive and comprehensive health benefits package
Easy-to-use benefits that promote wellbeing and make your life easier
Family friendly policies like parental leave
Award-Winning Workplace

Fulltime

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

Manager, Clinical Operations, International

Cabaletta is seeking a Manager/Sr Manager, Clinical Operations, International. R...

Location

Germany; Switzerland

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s Degree or advanced degree in life sciences or related field
Minimum 4 years of clinical trial management experience including management of study resources, vendors, budgets, supplies, critical path activities, and risk management, within Biotech or pharmaceutical industry or equivalent by experience
Cell therapy experience preferred and/or focus complex therapies
Fluency in English
working proficiency in additional European languages a plus
Experience with early phase, complex trials
Experience managing Contract Research Organizations and other external vendors
Good understanding of European regulatory requirements (EMA, MHRA, etc)
Working knowledge of GCP/ ICH regulatory guidelines
Extensive knowledge of standard industry practices related to study start-up, site management and monitoring, document management, and clinical supply management

Job Responsibility

Provide day-to-day clinical project management oversight of the full range of clinical operations activities associated with clinical trial conduct from protocol development, feasibility/capability assessments, initiation, execution, control, and closure
Perform hands-on activities not outsourced to vendors, as needed
Author study documents and plans such as ICF and study specific plans
Provide input and review of site training materials
Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
Proactively identify risks and lead team members to mitigate risks in a timely fashion
Develop and maintain positive relationships, both internal and external to project, including site personnel (KOLs, PIs, Study Coordinators)
Select and manage vendors
Perform and document study-level Sponsor Oversight of outsourced clinical activities
Execute clinical operations country submission tasks and documents: Review submission pack, coordinate country-specific ethics RFIs, review and update site-specific consent forms

What we offer

health and retirement
PTO
stock option plans

Lead Clinical Laboratory Scientist (CLS), Oncology

Join a team of brilliant, passionate innovators who wake up every day determined...

Location

United States , Menlo Park

Salary:

228788.00 USD / Year ▼

BillionToOne

Expiration Date

Until further notice

Requirements

Bachelor's degree in the chemical, physical or biological sciences
Minimum of 4 years of CLS experience in a clinical setting (molecular and/or high-complexity laboratory experience preferred)
A current California Clinical Laboratory Scientist License that meets requirements for Testing Personnel under CLIA regulations (42 CFR, part 493) (ASCP, CGMBS or generalist license is required)
Hands-on training and experience with manual molecular biology protocols, including DNA extraction, PCR, and automated liquid handlers
Advanced knowledge of Google Docs, Word, Excel, basic statistics and familiarity with LIMS systems and Next-Generation Sequencing
Strong attention to detail and ability to work flexibly and well under given timeframes.
Self-starter and dynamic team player with excellent verbal and written skills.

Job Responsibility

Lead clinical laboratory daily supervision in alignment with company values and mission
Hold General Supervisor delegation and responsibilities including oversight and support of day-to-day operations, scheduling, and troubleshooting
Manage CLIA direct reports including licensed and/or unlicensed staff (CLS, Clinical Laboratory Assistants)
Contribute to continuous process improvement projects including tech transfer, troubleshooting, training, and validations
Perform clinical laboratory assays to provide data for diagnosis, treatment, and prevention of disease
Perform quality control studies to ensure the accuracy of clinical data
Verify instrument performance by checking and calibrating specific lab instruments and documents data

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

Select Country

Clinical Laboratory Study Manager

Job Description

Job Responsibility

Requirements

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