Global Study Manager Job at iconplc

Manager, CSAR - Global Library

The Global Library Manager will report to the Sr. Manager, Clinical System and A...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree in life science, computer science, business administration or related field and 4 to 6 years of experience
Bachelor’s degree in life science, computer science, business administration or related field and 6 to 8 years of experience
Diploma in life science, computer science, business administration or related field and 10 to 12 years of experience
Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena
General project management and planning experience
Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.)
Good Clinical Practice knowledge
Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking
Knowledge of drug development and clinical trials processes
Knowledge of data management processes

Job Responsibility

Support of clinical trial platform technologies
Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight
Leading and / or coordinating the definition of studies in clinical trial databases or clinical systems
Coordinating and providing programming support to Clinical Study Teams
Maintaining standard business processes within GDO to ensure compliance to regulatory bodies
Acting as a technical point of contact for systems deliverables on defined programs
Providing technical and business process input / expertise on new and emerging technologies
Develop, review and implement policies, SOPs and associated documents
Assist in preparing for and responding to audit findings (internal or external)
Provide Global Library review at the study level

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Global Trial Manager - Early Development

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

Location

United States , CARY, BLUE BELL, RAHWAY, NJ

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

BA/BS/BSc or RN
At least 4+ years experience overseeing clinical trials including the oversight of Functional Service Providers, and outside vendors (CROs, central labs, imaging vendors, etc.)
Experience overseeing early phase studies (phase I) for biotech, pharmaceutical or CRO
Strong clinical project management skills and experience in driving milestones
Excellent communication and interpersonal skills to effectively work with cross-functional teams
Proficient in trial management systems and MS Project (or equivalent PM software)
Knowledge of ICH/GCP and regulatory guidelines/directives

Job Responsibility

Leads the study level planning and execution of overall operational deliverables, including study level forecast of investigational products and study logistics plan
Develops the strategic scenarios of designs for early phase clinical development plan
Ensures standard processes, tools, and procedures are used consistently
Routine engagement with Clinical Investigators
Provide oversight, support the design, and manage operational activities related to the planning, implementation, and reporting of outsourced Clinical Pharmacology studies
Leads, manages, and monitors overall study related activities including: Issues related to patient eligibility, enrollment and protocol deviations
Ongoing safety data review and completion of study data collection, data lock, and analysis
Resolution of cross-functional study-specific issues
Communication of study status to key stakeholder and updating relevant systems
Ensures study personnel are appropriately trained and understand study timelines and deliverables

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

New

Regional Study Coordinator

Labcorp is seeking a Regional Study Coordinator to join our team in Singapore.

Location

Singapore , Singapore

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Bachelor Degree in Life Sciences or Pharmaceuticals
3 months or more experience using computer and office software applications (e.g. Microsoft Word, Excel, MS-Access and Outlook)
Professional or internship experience in clinical research or pharmaceutical industry
Proficiency in Chinese language as liaising with China counterparts is expected
Strong interpersonal skills
Influence and negotiation skills
Demonstrated ability to plan and prioritize
Demonstrated communication and organizational skills
Demonstrated attention to detail
Demonstrated participation in process improvement initiatives

Job Responsibility

Be responsible for managing clinical projects to ensure the successful delivery of all lab services, including kits shipment, sample testing and sample management of a clinical study for the Asia region
Act as regional liaison between Labcorp Central Lab Services (CLS) Global Study Manager and various CLS departments involved in the clinical protocol
Close collaboration with the Global Study Manager for all study related aspects that are pertaining to the Asia platforms and through all study stages, from set-up to closure
Review the study Statement of Work, a document that specifies the scope of services CLS will perform for a clinical protocol and contains information approved by the sponsor and necessary to define the protocol specific database, to ensure regional feasibility and make appropriate recommendations to the Study Design Lead
Ensure a detailed knowledge of the Statement of Work specifications and very good understanding of how they impact every lab services aspect of the clinical trial
Manage day-to-day regional study related activities, including responding and resolving challenges in logistics, lab tests resulting, monitoring and study supplies, keeping the Global Study Manager informed of any study development
Monitor, track and provide resolution to all local study issues, keeping the Global Study Manager in the communication loop
Responsible for implementing monitoring and setting up of local performance metrics and taking corrective actions when needed
Liaise with the Global Study Manager for any tasks assigned to the Regional Study Coordinator as part of the Global Monitoring Plan
Demonstrate ability to work in a matrix environment where task assignments can be channeled down to be completed by Regional Study Coordinators while other task assignments will need to be delegated to other functional groups

Fulltime

Global Study Manager II - FSP

Location

United Kingdom

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor of Science or Bachelor of Arts degree with a minimum 7 years of relevant operational clinical trial experience required
Master of Science or Master of Business Administration degree with a minimum 6 years of relevant operational clinical trial experience required
A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology
Exceptional knowledge of study management processes and deliverables
Good knowledge in understanding the responsibilities beyond their function to ensure goals are met for the study
Maintains expertise within the assigned therapeutic area and study to set the appropriate strategy, identify risks and to drive operational deliverables
Working knowledge of Good Clinical Practices (GCPs), monitoring, clinical and regulatory operations
Experience in clinical research and/or study management
Study management/leadership experience
Experience with oversight of CROs and vendors

Job Responsibility

Leads and coordinates the execution of a clinical trial globally from sourcing strategy and study specification development for requests for proposals to fully outsourced studies and ancillary vendors, study start up through database release and inspection readiness to ensure timely delivery of quality study data
Provides quality oversight and coordination of regional and country operations and the pCRO for the tasks both owned by and delegated to Study Operational Managers (SOMs), if assigned to study, related to study execution
Provides leadership to the teams in setting recruitment targets and delivery milestones as the single point of accountability for detailed study start up, monitoring, and other study level plans and delivery to the agreed plans by partnering with cross functional colleagues
Serves as a critical member of the core team and represents the operational sub-team including applicable vendors and pCRO on matters of study execution
Drives decision making and works closely with the Clinical Study Team Lead (CSTL) to provide input to operational strategy
Provides supervision and/or mentorship to SOMs and possibly other GSMs
Ensures development of study level plans, including the study monitoring and study training plans
Develops, reviews, or approves the study startup, study monitoring, protocol recruitment, and training plans and other documents, guidelines, and plans
Approves and oversees drug supply management, manages flow of drug supply to the sites, and sets up interactive randomization systems with supply chain lead
Ensures overall vendor oversight for vendors managed by SOMs (if assigned), action escalations related to vendor issues and escalate further as necessary

Country Study Operations Manager - FSP

Parexel FSP is looking for multiple Country Study Operations Manager I! Candidat...

Location

Mexico

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor's of Science or Bachelor's of Arts degree with a minimum 5 years of relevant operational clinical trial experience required
Master's of Science or Master's of Business Administration degree with a minimum 3 years of relevant operational clinical trial experience required
A scientific or technical degree is preferred
Fluency in written and spoken English required
Ability to work outside of core business hours, as required, to support global trials or initiatives
Ability to travel, as required, including Investigator Meetings, vendor kick off and re-set meetings, and client internal global or department level meetings
Comprehensive knowledge of own discipline with good knowledge of other disciplines
Comprehensive knowledge in managing and coordinating specific tasks and responsibilities as part of a larger study management team
Working knowledge of Good Clinical Practice, clinical and regulatory operations, and environment in countries under responsibility
Demonstrated clinical research experience and/or study management/startup project manager experience

Job Responsibility

Supports Global Study Managers (GSMs), other SOMs, and the larger study management delivery of the study by leading specific parts of the project, driving specific countries, executing tasks of moderate complexity, and developing solutions to problems as needed to support deliverables
Serves as leader of the local study team (core members, ad hoc members, and other key stakeholders as required) on one or more studies
Oversees the preferred Contract Research Organization (pCRO) and/or Country Trial Manager (CTM)/Site Care Partner (SCP) for assigned studies at country level in accordance with the overall project plan, and manages and maintains accurate country level plans (e.g., timelines, budget, risk, and quality plans)
May manage the study start up process in countries assigned [where the Start Up Project Manager (SUPM) is not assigned] and/or oversee the pCRO responsible for these activities as applicable
Liaises with SCP, Lead SCP, Site Activation Partners (SAPs), and regulatory colleagues in country to agree on submission strategy to Health Authorities (HAs) and Ethic Committees (ECs)
Provides country level input on startup and recruitment milestones as provided by pCRO and/or CTM/SCP to GSM during planning
Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required
Accountable for resolution of site activation escalations to study teams including offering options for mitigation
May help guide the study management strategy by contributing local intelligence and providing accurate updates on delegated tasks to support establishment of critical path activities and risks
May independently take on activities with instruction provided as needed

What we offer

Benefits vary by country, but Parexel is passionate about our team's overall wellness

Fulltime