Clinical Project Manager Job at Beacon Hill (Indianapolis)

Clinical Project Manager

Permanent position available immediately located in Paris. The role involves lea...

Location

France , Paris

Salary:

Not provided

AB SCIENCE

Expiration Date

Until further notice

Requirements

Holder of additional training in methodology (CESAM, IUD, …)
Successful experience of Clinical Project Manager in a pharmaceutical company or CRO
6-8 year’s experience in clinical development (Phase II and III)
Experience in oncology or autoimmune inflammatory diseases would be a plus
Experience in international development required
Experience of the regulatory environment for clinical trials
Experience of writing research reports and FDA regulatory dossiers (IND, NDA) and EMA
Fluent in English

Job Responsibility

Design, implementation and coordination of clinical studies with the support of Clinical Operations, Pharmacovigilance, Biometrics and Medical Writing
Plan the clinical development program
Prepare studies protocols, amendments and reports
Prepare regulatory dossiers
Manage relationships with investigators and opinion leaders

What we offer

Salary and package to define according to skills and experience

Fulltime

Clinical Trial Manager/ Sr Clinical Trial Manager (PM/ Sr PM)

Clinical Operations Lead - Early Development Oncology. ICON plc is a world-leadi...

Location

United States , Raleigh, Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

BS/BA degree or a relevant degree with strong emphasis on science, or equivalent experience
Minimum of five years of relevant experience in the biopharmaceutical industry or other relevant clinical research experience, with a focus on skills and competencies
Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health
Prior experience in assisting the conduct and management of multinational clinical trials is preferred
Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously
Experience in oncology studies required (phase I preferred)

Job Responsibility

Participate as a member of a working group and perform special projects, as assigned, to improve the efficiency, effective and quality of the functioning of the Development Operations department
Act as preliminary liaison for study sites to convey study information, answer questions and in accordance with the escalation pathway
Develop relationships with investigational sites, HCPs, and institutions to enhance conduct of the trial
Monitor study-specific timelines and key deliverables
focus on management of all relevant external vendors (e.g., Monitoring, Sample management, IVRS, Laboratory, etc)
Participate as a member of the multi-disciplinary trial(s) team
Participate in coordinating efforts with internal Pharmacovigilance, and safety group as needed
Participate in data review and discrepancy resolution as needed
Assist in the development of the IP and co-medication strategy (quantities, labels, depots, tracking, etc.) working closely with other departments
Plan and organize meetings with team support (e.g., investigator/coordinator meetings, DMC, SMC, safety call, etc.) as appropriate

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

Clinical Project Manager - Post Trial Access

As a Project Manager - Post Trial Access at ICON, you will be responsible for le...

Location

Poland , Gdansk

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Experience in clinical research or biopharmaceutical operations
including 2+ years leading global, multi-regional PTA programs across the lifecycle, for investigational products prior to regulatory approval
comparable experience leading expanded access/compassionate use programs or significant experience contributing to PTA or EAP may be considered
General understanding of regulatory frameworks governing pre-approval and continued access to investigational products, ICH GCP, and ethical frameworks of clinical research
Demonstrated ability to manage mild to moderately complex, multi-region PTA programs involving investigational products with a degree of operational and regulatory complexity, with minimal supervision
Proven experience collaborating effectively
influencing stakeholders across functions and levels
Evidence of strong project management skills
including managing competing priorities and solving operational challenges in clinical or investigational program environments
Successful history of working independently in a global environment

Job Responsibility

Develop and manage timelines and budgets for post-trial access (PTA) programs supporting investigational products prior to regulatory approval
Lead cross-functional teams and serve as primary program contact for PTA/Continued Access programs
Populate PTA templates and tools with program-specific information related to investigational product access decisions and implementation
Drive development and finalization of core program documents (e.g. PTA Treatment Guidelines, PTA ICF, agreements and contracts)
Drive decision-making, including selection of appropriate regulatory mechanisms, supply strategy, and safety reporting, in collaboration with cross-functional stakeholders
with support as needed
Ensure alignment across PTA program decisions, documentation, plans, and implementation
Provide forecasting and ensure investigational supply strategies are developed and executed, in collaboration with Supply Chain, to facilitate uninterrupted patient access to investigational products
Manage vendor contracting and deliverables in support of PTA/continued access program execution

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

Fulltime

Clinical Project Manager - Maternity Cover

Are you ready to pursue your career within disruptive MedTech working with 3D sc...

Location

Denmark , Copenhagen

Salary:

Not provided

3Shape

Expiration Date

Until further notice

Requirements

Master's degree within a scientific field, preferably a PhD degree
Experience with managing clinical studies within the medical device industry
Strong knowledge of EU MDR, ISO 14155, and Good Clinical Practice (GCP)
Relevant clinical operation and medical/scientific writing experience in the medical device settings
Experience with post-market clinical follow-up (PMCF)
Strong organizational and communication skills, ability to manage multiple projects simultaneously
Fluent in written and oral English
Good team player with strong interpersonal skills
Ability to handle multiple tasks while managing tight deadlines

Job Responsibility

Lead the planning, execution, and delivery of pre- and post-market clinical investigations including post-market clinical follow-up in accordance with applicable regulations (e.g., MDR, ISO 14155, GCP)
Be responsible of clinical investigations documentation (clinical study protocols, informed consent form, patient information sheet, study contracts, application to relevant authorities, study reports and scientific publications)
Manage study timelines, budgets, and resources to ensure successful project delivery
Provide support regarding clinical investigation methodology (sample sizes, endpoints, analyses/statistics)
Ensure compliance with regulatory and ethical standards
Collaborate closely with internal stakeholders (Regulatory, Product Creation, Product Management, Marketing, Legal) and external partners (CROs, clinical sites)
Support the organization during internal and external audits
Provide input to PMCF, Post Market Surveillance (PMS), and vigilance activities based on e.g., risk management, input from customer and complaints
Provide support to Regulatory Affairs, Product Creation, Product Management, and other 3Shape functions as required
Contribute to continuous improvement of processes regarding clinical evidence, clinical operations and PMS based on knowledge of applicable regulations, guidance’s, and best practices

What we offer

Vibrant and international environment with social, diverse, and highly skilled and cooperative colleagues
Attractive healthcare package
Breakfast every day
Delicious and healthy lunch cooked by private chefs
Great social work environment with many optional activities and social clubs
Good work/life balance
Attractive offices and R&D lab spaces in downtown Copenhagen close to Kgs. Nytorv, Nyhavn, and the Copenhagen Canals
Purpose: Help improve dental care on a global scale

Fulltime

Clinical Project Manager - Early Phase Trials

As a part of the global Project Leadership group at Parexel, you are responsible...

Location

United States , Remote

Salary:

125000.00 - 138000.00 USD / Year

Parexel

Expiration Date

Until further notice

Requirements

2 years of Project Management experience with Parexel or 3 to 5 years in related fields
Experience as a Functional Team Leader or in coordinating clinical trials
Knowledge of ICH-GCP and pharmaceutical industry regulations
Proficiency in MS-Office products
Bachelor’s degree in a science-related field or equivalent work experience

Job Responsibility

Lead cross-functional teams to deliver high-quality and patient-focused clinical trials
Collaborate with clients and internal stakeholders to identify project requirements, develop project plans, and manage project timelines and budgets
Manage the financial aspects of projects, including revenue recognition, milestone payments, and monthly pass-through invoices
Own the sponsor relationship and manage sponsor communication
Serve as the central point of contact and escalation for functional teams
Proactively communicate project progress, risks, and solutions to sponsors and internal teams
Lead regular meetings with sponsors and project teams to ensure objectives are met
Review relevant materials and attend strategy meetings
Prepare for Bid Defense and develop project management strategies
Attend Bid Defense and handover meetings

What we offer

Annual performance-based bonus plan
Annual salary review
Additional total rewards incentives
Paid time off
401k match
Life insurance
Health insurance
Other benefit offerings in accordance with the terms of applicable plans

Fulltime

Clinical Project Manager I - Logistics & Sample Management

Our Clinical Project Management (CPJM) team plays a vital role in delivering hig...

Location

United Kingdom , Oxford

Salary:

33000.00 - 45000.00 GBP / Year

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Experience in clinical trials, logistics, or sample management
Strong organisational and problem-solving skills
Excellent communication skills (written and verbal)
Ability to manage multiple priorities under pressure
Proficiency in Microsoft Office

Job Responsibility

Lead the end-to-end coordination of sample shipments globally, ensuring compliance with regulatory and GCP requirements
Support day-to-day clinical project operations, working closely with internal teams to ensure smooth study delivery
Act as a key operational link between sites, couriers, CROs, and internal stakeholders
Contribute to continuous improvement of logistics and project delivery processes
Manage end-to-end coordination of international sample shipments, ensuring compliance with GCP and regulatory standards
Maintain accurate tracking and chain-of-custody records for all samples
Liaise with clinical sites, couriers, and central labs to plan and execute shipment
Support CPJM team with study management and day-to-day operations

Fulltime

Clinical Project Manager I

Our Clinical Project Management (CPJM) team plays a vital role in delivering hig...

Location

United Kingdom , Oxford

Salary:

33000.00 - 45000.00 GBP / Year

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

A degree in Human Sciences, Biological Sciences, or a related field
some experience in clinical trials or clinical research, such as in an administrative or coordinator role
excellent communication and interpersonal skills
strong organisational abilities and attention to detail
the ability to manage multiple tasks and priorities effectively
a proactive approach and enthusiasm for building strong working relationships

Job Responsibility

Coordinating project activities and timelines to support successful project delivery
engaging with internal and external stakeholders to maintain strong working relationships
supporting study management activities across clinical research projects
preparing, organising, and maintaining key project and study documentation

Fulltime

Clinical Project Manager III

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelo...

Location

United States , Bedford

Salary:

135000.00 - 155000.00 USD / Year

werfen

Expiration Date

Until further notice

Requirements

Medical Technologist degree or BS in STEM is preferred
Minimum of 4 years experience in clinical project or research management
Minimum of 2 years' experience leading CRAs
Experience in design and development of medical instrumentation
Clinical Research Associate (CRA) certification or equivalent certification in project management is desired
Working knowledge of Good Clinical Practice (GCP) / Good Study Practice (GSP) as described by US Food and Drug Administration (FDA), World Health Organization (WHO), International Conference on Harmonization (ICH), and International Standards Organization (ISO)
Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement
Problem solving, conflict management, listening, managing and measuring work
Strong project management skill set and familiarity with project management tools and techniques
Team player, self-motivated, perseverance

Job Responsibility

Provide technical and team leadership to one or more small clinical project team(s), including planning, scheduling, and technical leadership within the project area. Coordinate roles and responsibilities within the clinical project team
Responsible for clinical project planning and scheduling, utilizing deliverable milestone methods and critical path scheduling, and developing task and project estimates. At the Program Manager's, Clinical Research managers, or Clinical Director's request provide a schedule and budget forecast for the project
Responsible for conducting regular clinical project team status meetings and reviews. Plan and schedule technical reviews at appropriate clinical project milestones. Ensures deliverables are completed and documented according to Good Clinical Practice and per design control
Responsible for coordination of clinical project resources to identify the root cause(s) of clinical project issues, and develop and manage a plan to fix, test, and implement an appropriate solution through completion. If needed, coordinate with cross-functional team resources to support root cause initiatives
Responsible for insuring clinical project risks, both technical risks and management risks, are identified and appropriate risk mitigation plans are developed and executed. Track and respond to risk triggers. Regularly assess and report the status of overall clinical project risk to the development project team and Clinical Research Manager
Creates and maintains Trial Master File(s) and corresponding Design Control files to current study ensuring accuracy
Responsible for communication within clinical project team, development project team, and to clinical program management and department management. Develop and implement a project communication plan
Coordinates with study sites and internal service suppliers (i.e., Biobanking, Field Service Engineers, etc.) to ensure project deliverables are completed correctly and on time or that services are provided in accordance with the project plan
Able to identify and obtain support to resolve project team conflict. As necessary, work with development project leader to resolve cross-team conflicts. Able to remove oneself from the problem. Fosters creative, professional climate that will maximize the contributions of the multi-disciplinary clinical project team members
Participates in activities focused on improving the efficiency and effectiveness of the product development processes and procedures

What we offer

medical insurance
dental insurance
vision insurance
401k plan retirement benefits with an employer match
paid vacation
paid sick leave

Fulltime

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Clinical Project Manager

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