Study Start Up Project Manager - FSP Job at Parexel (Remote)

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

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

Global Site Start Up II - Spain/Poland/Serbia/Romania - FSP

If you want to be part of a leading CRO and transform scientific discoveries int...

Location

Spain

Salary:

220000.00 - 250000.00 PLN / Year

Parexel

Expiration Date

Until further notice

Requirements

Bachelor degree
Minimum 4 - 6 years global SSU management and 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
Ability to build productive study teams collaborations

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)

What we offer

Premium salary
Attractive benefits
Medical care plan: Health, Dental & Vision
Life Assurance
Excellent work environment
Culture of teamwork and collaboration
People who motivate and face challenges together
Innovative technology
Excellent training
Annual performance-based bonus plan

Fulltime

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 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

Clinical Operations Manager - FSP

Location

United Kingdom

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience required
5‐7 years clinical research or combined experience in Clinical Research and Finance/Business required
Expertise of core clinical systems, tools, and metrics
Excellent verbal and written influencing and training/mentoring skills, in English
Strong coordination and organizational skills
Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up
Able to indirectly influence investigators, vendors, external partners, and country managers to address and resolve issues, with minimal support from the SCOM or manager
Ability to make decisions independently with limited oversight from SCOM or manager
Requires a strong understanding of local regulatory environment
Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally

Job Responsibility

Attends meetings with COMs
Data Cleaning and Consolidation: Cleaning scattered data from different systems using Python and consolidating it into a unified reporting structure
Anomaly Detection: Establishing automated alert mechanisms to identify erroneous data entries and operational risks
Automating repetitive validation checks
Develop tools to support oversight - review trends
Build dashboard to support recruitment rates, trends, study timelines, real time operational oversight
API Integration: Enabling automated data flow between systems to reduce manual data transfers
Ad-hoc Analyses: Delivering fast, data-driven customized analyses to address urgent operational needs
Documentation: Preparing technical documentation and guides for the developed tools and code structures
SME & PoC Activities: Managing pilot projects for the integration of new technologies (AI/ML) into processes and providing technical SME support to teams

Clinical Study Physician - Oncology - FSP

Parexel FSP has an exciting opportunity for a Clinical Study Physician. This is ...

Location

United States , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Physician MD, ideally with medical thesis, trained in a clinical setting
Minimum of 4 years of active clinical experience
specialization in internal medicine or general practice preferred
Experience in the pharma industry or CRO in medical, project management or global pharmacovigilance functions/any other relevant medical function, ideally in Clinical Development
Understanding of relevant regulations and guidance including ICH-GCP
Experienced with data visualization systems and IT systems
Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook)
Proficiency in written and spoken English and (local language)
Excellent interpersonal, active listening and influencing skills
Pronounced analytical skills and systematic and well-structured working style

Job Responsibility

Trial Start-Up: Responsible for medical content of Clinical Trial Protocols (CTPs)
Contribution to trial risk-based quality management from medical perspective
Medical responsibility as co-author for the development of a robust Clinical Quality Monitoring Plan (CQMP)
Responsible for providing medical input into the definition of important protocol deviations (iPD)
Contribution to the timely preparation of medically relevant core trial documents and timely milestones
Medical input into Data Management documentation for the trial
Responsible for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, and Trial Statistical Analysis Plan
Medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report
Contribute to the medical content of responses to questions from regulators and Ethic Committees/IRBs
Medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans

What we offer

Flexible approach to work that meets your personal needs while maintaining quality delivery for patients
Choose the right work arrangement for you - in-office, home-based or a mix
Benefits vary by country, but Parexel is passionate about our team’s overall wellness
Investing in your professional and personal development is an investment in Parexel, and we want to help you realize your full potential and career

Fulltime

Study Physician - Oncology - FSP

The Study Physician (SP) is a critical global role that is created to take up me...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook)
Proficiency in written and spoken English and (local language)
Excellent interpersonal, active listening and influencing skills
Pronounced analytical skills and systematic and well-structured working style
Pronounced presentation and training skills
Capability to work proactively and with team spirit in an international environment
Ability to use digital technologies to access information, be creative, innovate, solve problems, communicate, navigate, learn & apply in a digital environment
Experience in the pharma industry or CRO in medical, project management or global pharmacovigilance functions/any other relevant medical function, ideally in Clinical Development, with required capabilities
Understanding of relevant regulations and guidance including ICH-GCP
Experienced with data visualization systems and IT systems

Job Responsibility

Trial Start-Up: Responsible for medical content of Clinical Trial Protocols (CTPs)
Contribution to trial risk-based quality management from medical perspective
Medical responsibility as co-author for the development of a robust Clinical Quality Monitoring Plan (CQMP)
Responsible for providing medical input into the definition of important protocol deviations (iPD)
Contribution to the timely preparation of medically relevant core trial documents and timely milestones
Medical input into Data Management documentation for the trial
Responsible for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, and Trial Statistical Analysis Plan
Medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report
Contribute to the medical content of responses to questions from regulators and Ethic Committees/IRBs
Medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans

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Study Start Up Project Manager - FSP

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