Clinical Operations Manager - FSP Job at Parexel

Associate Vice President, Clinical Data Management

The Associate Vice President, Clinical Data Management is a member of the Global...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s or master’s degree with 25+ years of data management experience
10 to 15 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Experience within clinical data management, regulatory compliance, and strategic leadership within a pharmaceutical, biotech, or CRO environment
Expertise in GCP, ICH, FDA, EMA regulations, data governance, and clinical trial data standards (CDISC, SDTM)
Experience within cross-functional collaborations, leadership, and strategic planning skills, ensuring operational excellence and compliance while driving innovation in data management to support Amgen’s global clinical development efforts
Expertise in AI/ML-driven data management solutions, automation, and advanced analytics
Understanding of clinical data standards (CDISC, SDTM, ADaM)
Experience leading regulatory submissions, including NDA/BLA/MAA filings and advisory committee interactions
Proven ability to drive organizational change, optimize processes, and implement lean principles in clinical data management
Cross-functional collaboration experience with clinical operations, regulatory affairs, biostatistics, and R&D teams

Job Responsibility

Develop and drive the global data management strategy in alignment with clinical development objectives and corporate goals
Provide strategic and operational leadership to the Clinical Data Management (CDM) function across all clinical programs and phases
Lead innovation initiatives, including the implementation of development integration programs and the adoption of cutting-edge technologies to enhance data workflows
Represent Clinical Data Management in executive leadership discussions, regulatory interactions, and industry forums
Establish and enforce robust clinical data governance models, policies, and risk mitigation strategies to ensure quality and compliance
Make final decisions regarding standard operating procedures (SOPs), CDM best practices, and process optimization
Engage key stakeholders and ensure timely resolution on critical data integrity and regulatory compliance issues
Serve as the primary CDM representative during regulatory inspections and audits, with responsibility for final decisions on findings, responses, and corrective actions
Influence cross-functional clinical development, operational, and regulatory strategies through data-driven insights and analytics
Partner closely with Clinical Program Operations, Regulatory, Biostatistics, and R&D to ensure seamless integration and alignment of clinical data

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

Senior Manager, Clinical Operations/ Senior Global Trial Manager - FSP

Parexel are currently recruiting for an experienced Global Study Operations Mana...

Location

Italy; United Kingdom , Remote; Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Minimum of 7 years of relevant clinical trial management experience
Global trial management experience is essential
Experience managing CRO outsourced studies is essential
Excellent leadership, communication, and organizational skills
Able to multi-task under limited direction and on own initiative
M.S/M.A/Ph.D or B.A/B.S/nursing degree is essential
Prior and demonstrable experience working at a senior level within Study start up preferred

Job Responsibility

Accountable for the end-to-end clinical trial delivery
Providing operational leadership and oversight of cross-functional deliverables
Leading a cross functional trial team to build and deliver the trial operational plan
Responsible for leading the Cross functional trial team to influence and execute delivery of the operational plan and for end-to-end trial execution
Accountable for overall trial delivery, budget, timelines, quality, and milestones
Oversight of all aspects of CRO/vendor identification, set up, statement of work creation, budget oversight and performance (KPI’s and metrics)
Proactively ensure that trial deliverables and milestones are met according to corporate and study-level goals
Identify risks and ensure mitigations and contingencies are being initiated and followed through
Ensure trial Is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes
Participate in preparation for, and conduct of, Health Authority Inspections and internal QA audits

Study Operations Manager/Clinical Trial Manager - FSP

The Study Operations Manager I (SOM I) has responsibilities for study and region...

Location

United States

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

Job Responsibility

Serves as leader of the local study team on one or more studies
Provides back up to or assumes the responsibilities of the GSM as needed
Oversees the preferred Contract Research Organization and/or Country Trial Manager/Site Care Partner 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 and/or oversee the CRO responsible for these activities as applicable
Liaises with SCP, Lead SCP, Site Activation Partners and regulatory colleagues in country to agree on submission strategy to Health Authorities (HAs) and Ethics Committees (ECs)
Provides country level input on startup and recruitment milestones 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
Fully responsible and accountable for, as designated by the GSM: Regional, country, and study level implementation of startup and site activation plans
Regional, country and study level recruitment strategy

Central Monitor - FSP

The Central Monitor (CM) plays a key role for Data Surveillance by overseeing an...

Location

Serbia

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

University degree in life science, business or operations
Fluent in both written and spoken English
≥ 5 years of recent pharmaceutical industry experience, with previous experience in clinical research, in a Pharmaceutical Industry or CROs
Strong clinical experience with excellent understanding of clinical trial development and risk management processes and the management of clinical trials
≥ 3 years comprehensive experience in monitoring (central, site), additional experience in clinical data analytics, data management activities or equivalent is preferable
Specific Central monitoring / monitoring experience (hands-on experience with KRIs review, centralized monitoring and quality tolerance limits -QTLs-) are strongly preferred
Knowledge of Risk-Based Quality Management (RBQM) and adaptive monitoring principles
Knowledge of overall clinical trial management process, understanding of the protocol, study associated risks and their significance, and the risk management process
Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH)
Critical thinking and analytical skills to understand/analyze complex data and provide insight into risk signaling, trends, and outliers in data

Job Responsibility

Implement and execute centralized monitoring strategies to support clinical trial oversight
Conduct ongoing central monitoring analysis of clinical trial data to detect trends and signals
Work with Data Analysts team in reviewing CM technology outputs and performing an initial investigation of identified risks (e.g., atypical data patterns) to assess their scope and nature in preparation for review with study teams
As needed, provide input into the data domains required for central monitoring as per the monitoring strategy
Ensure adherence to risk-based monitoring plans, SOPs, and industry best practices
Perform data surveillance via the CM platform, identifying potential sites or trial risks in alignment with the IQRMP
Collaborate with Lead CM and study teams to refine and implement risk-based monitoring plans
Provide insights and recommendations to enhance trial efficiency and mitigate risks
Support root cause analysis for identified issues and suggest corrective actions
Generate and summarize findings within the CM platform and lead the communication of results to study teams and RSL

Country Study Operations Manager/Clinical Trial Manager - Fsp

The Study Operations Manager has responsibilities for study and regional or spec...

Location

Canada

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

Job Responsibility

Serves as leader of the local study team on one or more studies
Provides back up to or assumes the responsibilities of the GSM as needed
Oversees the preferred Contract Research Organization and/or Country Trial Manager/Site Care Partner 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 and/or oversee the CRO responsible for these activities as applicable
Liaises with SCP, Lead SCP, Site Activation Partners and regulatory colleagues in country to agree on submission strategy to Health Authorities (HAs) and Ethics Committees (ECs)
Provides country level input on startup and recruitment milestones 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
Fully responsible and accountable for, as designated by the GSM: Regional, country, and study level implementation of startup and site activation plans
Regional, country and study level recruitment strategy

Fulltime

Study Start Up Project Manager - FSP

The Start Up Project Manager is responsible for defining, developing and deliver...

Location

Canada , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Country or Regional start up exposure/experience in the countries under responsibility across at least two major therapeutic areas
Technical expertise in use of software (off the shelf and custom) for the management of clinical studies with prowess in using reporting systems (dashboards and associated basic data analysis) to comprehend and communicate status
Ability to use basic generative artificial intelligence techniques in daily work
Will use standard risk management methodology to identify and mitigate key risks
Fluency in English is required
Extensive global start up clinical trial/study management experience
Comprehensive working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
Extensive knowledge of clinical trial methodology
Demonstrated start up experience
Demonstrated project management experience

Job Responsibility

Define, develop and deliver the global start up project strategy by partnering with roles across GSSO, CD&O, Global Regulatory Submissions and others as required
Manage and coordinate study start up activities globally
Lead the start up sub team for the study, region(s) or countries assigned
Partner with country/site feasibility specialists to incorporate up to date intelligence for the planned countries and sites into the overall start up strategy and site activation plan
Partner and co-ordinate across teams responsible for regulatory submissions (local and country) and start up functions to align country and site activities
Continually assess current and future workload to proactively anticipate, problem solve and request appropriate changes
Provide project management of activities directly required to complete all site activations
Lead start up meetings that facilitate alignment of site selection to activation activities
Work with country level start up roles to seek opportunities to accelerate site activations
Accountable for quality and completeness of start up timeline plans at study, country and site level

Fulltime

Start Up Project Manager II- FSP

The Start Up Project Manager is responsible for defining, developing and deliver...

Location

Canada

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Demonstrated clinical research experience
Demonstrated start up experience
Demonstrated project management experience
Global start up experience (Exposure across a minimum of North America, Asia and Europe) across multiple therapeutic areas
Concurrent management of complex processes within and across countries in multiple regions of the world
Technical expertise in the use of software for the management of clinical studies (enterprise project management, off the shelf and custom built) including reporting systems (dashboards with associated medium to complex data analysis)
Expert ability to comprehend status and adapt communications across a diverse audience
Perform critical path analysis across multiple related project plans, will use key performance indicators to assist in driving overall delivery to operational plan across roles
Will use generative artificial intelligence techniques in daily work
Uses risk management techniques as standard to identify and mitigate key project delivery risks

Job Responsibility

Partner with country / site feasibility specialists to incorporate up to date intelligence for the planned countries and sites into the overall start up strategy and site activation plan, most typically on studies with a medium to large country and site footprint
Partner and co-ordinate across teams responsible for regulatory submissions (local and country) and start up functions (e.g. site essential document collection, site contracts and budgets) to align country and site activities, will have ability to form a robust startup strategy and site activation plan for operationally complex studies
The SUPM is responsible for delivering site activations to plan, for the SUPM II this will generally be for studies with higher operational complexity (based on a combination of factors such study design, country and site footprint and the priority of the study)
As part of the responsibility of delivering site activations to plan the SUPM will co-ordinate with many different roles working at the study and country level to oversee progress of the study specific (e.g. Vendor set-up, investigational product supply etc.) or country specific tasks (e.g. Regulatory submissions, importer of record for supplies etc.) that need to be completed in order for site activations in turn to complete
Provide project management of activities directly required to complete all site activations for an assigned study as part of a study management led team to complete all start up activities for a study
Lead start up meetings that facilitate alignment of site selection to activation activities performed by country level start up roles with the endorsed trial optimization plan (by senior leadership)
The SUPM will work with country level start up roles to seek opportunities to accelerate site activations for their study
Accountable for quality and completeness of start up timeline plans at study, country and site level within an enterprise project management (EPM) system
Responsible for creating and overseeing the initial baseline and subsequent snapshots of timeline planning within the EPM system
In conjunction with study management roles is responsible for ensuring consistent participant compensation for sites and institutions taking part in multiple studies concurrently to eliminate knock-on impact across studies

Select Country

Clinical Operations Manager - FSP

Parexel

Location:
United Kingdom

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
February 19, 2026

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Clinical Operations Manager - FSP

Parexel

Location:United Kingdom

Category:IT - Administration

Contract Type:Not provided

Salary:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:February 19, 2026

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Job Posted:
February 19, 2026