Global Study Manager II Job at Parexel

New

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

Global Study Manager

Global Study Manager – This position is a fully client-embedded role, dedicated ...

Location

Poland

Salary:

Not provided

myGwork - LGBTQ+ Business Community

Expiration Date

Until further notice

Requirements

Bachelor’s degree: life sciences or related discipline
At least 5+ years of relevant study management experience on a global level
In-depth experience in clinical research: study management, monitoring, data management
Must have exposed to clinical study management “end-to-end” Globally : NA, EMEA, APAC, LATAM – China & Japan, Africa is an asset
Must have proven experience from study feasibility to CSR
Must have at least Ph II and PIII experience – PI & PIV is an asset
Must have cross-functional leadership proven experience, able to drive internal and external meeting
Able to input in clinical protocol, ICF, and other study plan, savvy in clinical study risk management and clinical systems
Strong experience in clinical budget management
Strong experience with vendor management including CRO

Job Responsibility

Accountable for delivering the clinical operation activities of the study until study archiving
Generating robust and accelerated delivery plans (with a focus on upper quartile performance) and delivering these to target or stretch thresholds and with quality
Accountable for the operational delivery of clinical study/studies to time, quality, and budget, company standards and scientific requirements, supporting decision -making at pace and leading study team to achieve overall study deliverables
Accountable for the following deliverables: Study Initiation Meeting, Clinical Study Activity Plan, Study Delivery Plan, TMF Quality Strategy Document, DCT Set Up, Vendors Oversight Plan, Investigator/CRA Meeting Set Up & associated training, Recruitment Tracking, Budget tracking eTMF filing and Vendor Set Up and Management, Safety Management plan, eTMF & vendor set -up
Proactively and effectively identifies, oversees, and mitigates study risks
Ensures appropriate stakeholder communication, including study status, expectations, risks and issues
Accountable to operate within the study budget
Effectively leads empowered matrix teams
Responsible for operational input into protocol and informed consent form development, and other key study documents
Leads and conducts investigator meetings and other study related meetings

Fulltime

New

Global Study Manager II

Parexel is actively recruiting for an experienced Global Study Manager to join u...

Location

Poland

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor’s degree and minimum 6 years of relevant global study management/leadership experience
Experience with oversight of CROs and vendors
Experience in managing per subject costs, vendor and ancillary and monitoring costs projections and spend
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 IMs, vendor kick off and re-set meetings, and client internal global or department level meetings
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

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
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

Fulltime

Country Risk Analyst II

The Country Risk Analyst II is a developing professional role under Wealth Retai...

Location

Singapore , Singapore

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

0-2 years relevant experience
Working knowledge of data management tools such as Python, R, SAS, and other analytics tools
Knowledge and understanding of Accounting and Financial Concepts
Financial analysis
Highly detailed and analytical abilities, with a keen sense on data trends and data quality checks
Business and/or product knowledge
Ability to exercise autonomous thinking and balanced judgement
Ability to work to tight deadlines
Ability to work in a team environment
Excellent communication skills

Job Responsibility

Performs industry analysis and develops domain expertise for focus industry segments including preparation of industry studies
Identifies and analyzes situations that create risk and legal liability for Citi, utilizing various resources such as credit reports, score cards, risk systems, and knowledge of the elements of Risk
Establishes and maintains consistent standards and processes in credit analysis through interaction with industry specialists and analysts globally
Takes responsibility for the analysis of the individual credits
Performs detailed analysis for complex credit recommendations (consumer, issuer, acquirer, and vendor) to ensure appropriate risk/reward balance, including contract analysis and negotiations
Assesses Citi products and their appropriateness for the obligors
Prepares financial forecasts and provides financial updates for credit reviews
Coordinates and communicates with industry units internationally
Identifies key risks and material changes
highlights to Risk Managers

What we offer

Extensive on-the-job training
Exposure to senior leaders
Volunteerism opportunities
Resources to enhance financial well-being and healthy decision-making
Development opportunities

Fulltime

Site Care Partner II

The Site Care Partneris a key Pfizer point of contact for investigative sites th...

Location

Taiwan , Taipei

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience (estimate at least 7 years’ experience)
Proficiency in local language preferred. English is required
Work as SCP I experience above 2 years
Demonstrated experience in site management with prior experience as a CRA/ Site monitor
Demonstrated experience in start up activities through to site activation
Demonstrated experience in conduct and close out activities
Demonstrated knowledge of quality and regulatory requirements in applicable countries
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
Must demonstrate good computer skills and be able to embrace new technologies
Excellent communication, presentation and interpersonal skills

Job Responsibility

Accountable for site start-up and activation
Deploy GSSO site strategies by qualifying and activating assigned sites
Supports processes to optimize country & site selection activities including review and assessment of the draft potential site list & provide PTA output for site selection
Supports the Feasibility Strategy and Analytics Lead to ensure that high quality feasibility results are delivered
Collaborate with key stakeholders providing country/regional level input to country outreach surveys including protocol feasibility, country SOC and medical practices (as applicable)
Provide country/regional level input to country strategy, feasibility and protocol design in collaboration with relevant Medical Affairs colleagues, and with input from external clinical experts as required
Maintain a knowledge of assigned protocols
Conduct study start up activities at the site level including but not limited to PTA, coordination of site activation checklist items, ICD finalization, SIV (as applicable), including management of issues that may compromise time to site activation
Ensure all the site initiation activity including training per site activation checklist, collect and / complete necessary documentation/ systems needed for site activation. (e.g. PSR, SART, ESRA, SAC, FU Letter, Planisware, ISF/eISF etc.)
Support country specific ICD review and deployment when applicable

Fulltime

Global Site Start Up II

In this role you will be is accountable for the global execution of site activat...

Location

Serbia

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor degree
Minimum 4 - 6 years regulatory submission experience, regulatory document management in Pharmaceutical /CRO industry
understanding of clinical study start up requirements and working knowledge of relevant documentation
Project Management and Clinical Trial Management experience is a must
Demonstrated interpersonal & leadership skills
Ability to understand and implement the operational strategic direction and guidance for respective clinical studies
A data driven approach to planning, executing, and problem solving
Effective communication skills via verbal, written and presentation abilities
Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
Ability to influence and negotiate across key stakeholders

Job Responsibility

Develop the site start up strategy for each study, outlining all dependencies impacting site activation and actively mitigating and escalating risks
Oversee the tracking and analysis of study metrics, including risks and mitigation strategies and to evaluate CRO performance and implement corrective actions
Advocate for optimized site selection strategies, leveraging data-driven insights to guide cross-functional teams toward effective decision-making
Lead the development, assessment, and alignment of site activation projections, ensuring cross-functional and CRO collaboration to meet strategic objectives
Ensure comprehensive and compliant documentation of site start-up materials in the Trial Master File (TMF) to maintain inspection readiness
Partner with cross functional and CRO partners (where applicable) to develop a comprehensive global country start up strategy, outlining all dependencies impacting country start up and actively mitigating and escalating risks cross functionally
Monitor and maintain country intelligence data to support informed decision-making and develop accurate startup projections and strategic plans
Support regulatory submissions as needed, including activities such as providing required site documentation, coordinating submissions to Central Institutional Review Boards (CIRBs), supporting sites with Local Institutional Review Board (LIRB) submissions, and handling or supervising Clinical Research Organization (CRO) insurance requests, etc
Ensure timely country submission deliverables (ensure task completion
all roles clarity, identification of critical path items, effective communication pathway)

Fulltime

Senior Clinical Research Associate II - FSP

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

Turkey

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Monitoring Experience: Minimum 5 years relevant experience in clinical research site monitoring (preferably 3 years in Oncology)
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Global clinical trial experience
Must be fluent in English and in the native language(s) of the country they will work in
Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
Valid driver’s license and passport required
Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)

Job Responsibility

Oversight of Monitoring Responsibilities and Study Conduct
Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution

What we offer

Flexible work arrangements
Career growth and development
Supportive and inclusive environment
Diverse therapeutic areas and project exposure
Advanced Technology

Compliance Analyst

insightsoftware is seeking a detail-oriented and proactive Compliance Analyst to...

Location

United States , Remote

Salary:

Not provided

insightsoftware

Expiration Date

Until further notice

Requirements

Bachelor's degree in information security, Cybersecurity, Computer Science, Risk Management, Legal Studies, Business Administration, or related field
Minimum 3+ years of experience in compliance program management, risk management, or information security roles, preferably in regulated industries or technology companies
Demonstrated experience responding to third-party risk assessments, security audits, customer security questionnaires, RFPs, and compliance due diligence requests
Working knowledge of regulatory frameworks and standards (e.g., ISO 27001, SOC 2 (Type II), NIST, FedRAMP, CMMC, PCI DSS, GDPR, CCPA), trade control regulations (EAR, ITAR), anti-bribery/corruption laws (FCPA, UK Bribery Act), and data privacy principles
A strong knowledge of at least one regulatory framework governing matters pertaining to data privacy, cybersecurity, trade compliance, or third-party risk management
Experience with third-party screening tools and vendor risk management platforms
Familiarity with GRC or data protection management platforms (e.g., OneTrust, ServiceNowMetricStream)

Job Responsibility

Support the development, implementation, and maintenance of a global compliance program, including trade compliance, anti-bribery/corruption, anti-trust, and business ethics
Conduct secondary screening of third parties (vendors, partners, customers) , and assess potential matches against government watchlists of denied, debarred, sanctioned, or restricted parties to ensure compliance with applicable trade compliance, export control and sanctions regulations (e.g., U.S. Department of the Treasury Office of Foreign Assets Control ("OFAC"), U.S. Department of Commerce Bureau of Industry and Security ("BIS"), U.K. Office of Financial Sanctions Implementation ("OFSI"), European Union, and United Nations)
Assist with export classification determinations and licensing requirements for software products and services, including evaluation of Export Control Classification Numbers ("ECCNs")
Support the company's compliance with applicable data protection regulatory frameworks (e.g., GDPR, CCPA)
Support the Corporate Counsel, Data Privacy, AI, Cybersecurity with data protection initiatives and obligations including data mapping exercises, processing activity records, and privacy impact assessments, and coordinate responses to data subject access requests ("DSARs") and privacy-related inquiries
Support privacy management tools and platforms for consent management and privacy workflow automation
Partner with company counsel, InfoSec, and other stakeholders with compliance audits, data privacy questionnaires, and third-party risk assessment processes including vendor due diligence and ongoing monitoring
Support risk and control self-assessments ("RCSA"), audit management, and remediation tracking
Collaborate with stakeholders including the Chief Information Security Officer ("CISO") and the team to quantify, monitor, and report on security and compliance performance
Maintain GRC platforms (e.g., ServiceNow, Archer, MetricStream) to track compliance activities, risks, and controls

Global Study Manager II

Parexel

Location:
Poland; Spain; Serbia; Romania

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
April 24, 2026

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

Similar Jobs for Global Study Manager II

Global Study Manager II - FSP

Global Study Manager

Global Study Manager II

Country Risk Analyst II

Site Care Partner II

Global Site Start Up II

Senior Clinical Research Associate II - FSP

Compliance Analyst

Global Study Manager II

Parexel

Location:Poland; Spain; Serbia; Romania

Category:Research and Development

Contract Type:Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:April 24, 2026

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

Similar Jobs for Global Study Manager II

Global Study Manager II - FSP

Global Study Manager

Global Study Manager II

Country Risk Analyst II

Site Care Partner II

Global Site Start Up II

Senior Clinical Research Associate II - FSP

Compliance Analyst

Location:
Poland; Spain; Serbia; Romania

Category:
Research and Development

Contract Type:
Not provided

Job Posted:
April 24, 2026