Site Activation Partner - FSP Job at Parexel

Site Activation Partner - FSP

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

Location

Canada

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

School diploma/certificate with equivalent combination of education, training and experience
BS/BA or bachelor's degree in life sciences preferred
Minimum 2 years relevant experience in Clinical Trials environment and clinical site activation
Experience working in the pharmaceutical industry/or CRO is an asset
Knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations
Must be fluent in Local language and in English
Multi-language capability is an asset
Communicator
Detail-oriented
Flexible

Job Responsibility

Initiate and coordinate activities and essential documents management towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for sites initiation
Provide support to resolve issues or concerns and timely escalation of Site issues where applicable
Manage and coordinate with other supporting roles to ensure timely site activation and operational activities
Collaborate with in country regulatory group, and provide related/applicable site documents, as well as in countries where parallel submissions (Regulatory authority and ethics) are required
Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines
Identify and resolve investigator site issues

Investigator Contracts Lead - FSP (Site Contracts Lead)

Key Accountabilities: Contracting deliverables. Exercise good judgment in balanc...

Location

Australia

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience with clinical study budgets and contracting negotiation principles, practices, processes, and activities
Knowledge of the principles, concepts and theories in applicable business discipline
Experience in drafting and negotiation of Clinical Trial Agreements with clinical trial sites in a global operation preferred
Bachelor's Degree or equivalent and 5+ years of experience in clinical development operations or clinical trial outsourcing OR Juris Doctorate or equivalent and 2+ years of experience in clinical development operations or clinical trial outsourcing
Balance of general business, compliance, finance, legal, and drug development experience
Precise communications and presentation skills
Ability to plan, identify and mitigate risks to site contacting timelines
Ability to lead by influence rather than positional power to accomplish critical deliverables
Success in working in a highly matrix based organization
Fluency in written and spoken English is required

Job Responsibility

Lead study level site contracting activities, direct other ICL and act as primary study point of contract for site contracting issues and timelines on assigned studies
Partner with Legal and other divisions to manage escalations in the site budgeting and contracting space
Partner with Legal, Finance, pCRO and other divisions to identify and implement areas of improvement in the site contracting space
Applies acquired job skills and procedures to complete substantive assignments, projects and tasks of moderate scope and complexity in applicable discipline
Lead and develop relationships with key investigational sites and Site Management Organizations across the contracting and budgeting interface
Collaborates with invoicing specialists and/or invoice service provider to ensure alignment with Investigative Site contracting and compensation requirements
Interacts with clinical site contracts & legal contacts, client and partner legal team, study management, site payments team, peer site contracting colleagues, CRO site contracting teams
Contributes to design, development and implementation of major business initiatives or special projects

Site Contracts Lead - FSP

The Investigator Contracts Lead is responsible for direct site facing contract a...

Location

Canada

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience with clinical study budgets and contracting negotiation principles, practices, processes, and activities
Knowledge of the principles, concepts and theories in applicable business discipline
Experience in drafting and negotiation of Clinical Trial Agreements with clinical trial sites in a global operation preferred
Bachelor’s Degree or equivalent and 5+ years of experience in clinical development operations or clinical trial outsourcing OR Juris Doctorate or equivalent and 2+ years of experience in clinical development operations or clinical trial outsourcing
Balance of general business, compliance, finance, legal, and drug development experience
Precise communications and presentation skills
Ability to plan, identify and mitigate risks to site contacting timelines
Ability to lead by influence rather than positional power to accomplish critical deliverables
Success in working in a highly matrix based organization
Fluency in written and spoken English is required

Job Responsibility

The Investigator Contracts Lead is responsible for direct site facing contract and budget negotiations through contract execution with assigned clinical investigator sites including initial agreements and amendments and oversight of other contracting professionals on assigned studies
Managing the Per-Subject Cost (PSC) process for assigned studies
Managing escalation and resolution for budget and non-legal term issues from other ICL or preferred Contract Research Organizations (pCRO)
Collaborating with other lines to plan site contracting timelines though start up
Contracting deliverables
Exercise good judgment in balancing the risks to the client in making budget and contractual decisions against the impacts to client clinical trial timelines
Follow client processes to develop, negotiate, track and execute global clinical study agreements with institutions and investigators participating in sponsored clinical trials
Work with partners to develop and oversee the global site budget process
Work with clinical trial sites and directly negotiate cost, business and contractual terms and conditions with investigators/institutions, making changes to contract templates within the Legal division approved parameters
Lead study level site contracting activities, direct other ICL and act as primary study point of contract for site contracting issues and timelines on assigned studies

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

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/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

Senior Clinical Research Associate - Midwest/Central US - FSP

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

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
Must be fluent in English and in the native language(s) of the country they will work in
Ability to travel 60-80%
Valid driver's license and passport required

Job Responsibility

Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's 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
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities
Monitor site level adverse events (AEs) and serious adverse events (SAEs)
Submit all required reports, documentation, updates and tracking within required timeframes
Identify and resolve investigator site issues within required timeframes
Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines

Fulltime

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Site Activation Partner - FSP

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