Clinical Trials Operations Specialist

3 dni temu

Poland MyGwork Pełny etat

Clinical Trial Manager Job Description

 

As a Clinical Trial Manager at Thermo Fisher Scientific, you will be responsible for the successful execution of clinical trials from start to finish. This includes managing global clinical trial operations, overseeing CROs and vendors, and ensuring compliance with regulatory requirements.

 

Key Responsibilities:

  • Manage cross-functional execution of assigned global clinical trial(s) from preparation until closure
  • Establish and lead the cross-functional Clinical Trial Team (CTT) in partnership with the Lead Trial Physician
  • Work with functional leaders to assign CTT representatives from involved functional areas
  • Ensure clinical trials are executed according to protocol requirements, trial plans, OGSM, client procedures, ICH-GCP, and other applicable regulations
  • Communicate in a transparent, clear way, and collaborate with CTT members & external partners to achieve clinical trial objectives
  • Oversee cross-functional planning, track study progress, and proactively manage completion of trial deliverables and milestones
  • Responsible for leading, guiding, and overseeing CROs and other vendors to ensure contractual obligations are met according to plan and metrics
  • Manage CTT risk identification & mitigations, suggest and collaborate on solutions, manage contingency planning, and oversee implementation
  • Manage the implementation of corrective and preventative actions as needed
  • Maintain awareness of risks or issues that could have cross-indication, cross-franchise, or cross-asset impact and escalate to the (Franchise) CODL, Head of Trial Operations, and/or Senior Management as needed
  • Contribute to the evaluation, selection, and contracting of CROs and vendors
  • Ensure scope of work aligns with protocol requirements and established budget and timelines
  • Oversee contract management and ensure services are delivered per contract
  • Ensure accurate trial budget management, timely management of scope changes, and budget reconciliations
  • Ensure CTT members, including CRO and vendor teams, receive appropriate trial-specific training for their function
  • Oversee setup, coordination, and conduct of Investigator Meetings
  • Develop and/or contribute to trial-related materials such as the clinical protocol, study training materials, pharmacy manual, clinical monitoring plans, data management plan, e CRF and associated completion guidelines, patient information and informed consent, site instructions for specimen collection, patient recruitment and retention materials, etc.
  • Act with the mindset of reducing patient & site burden throughout the trial
  • Ensure vendor systems and processes are configured according to protocol requirements & applicable regulations and implemented within established timelines
  • Contribute to the development and approval of project specifications, user acceptance testing, implementation, and change management
  • Oversee the country and site feasibility process, ensure cross-functional alignment on regional footprint
  • Ensure timely availability of investigational product on site and ensure clinical site accountability records are in place and maintained
  • Perform site oversight visits according to plan
  • Review monitoring visit reports, protocol deviations, and data listings to ensure reliable quality data are delivered
  • Monitor data quality, completeness, and timeliness
  • Proactively identify and manage resolution of issues/concerns
  • Partner with client Site & Patient Engagement, CRO, and other vendors on recruitment & retention tactics that engage patients & sites and foster positive experiences
  • Ensure supportive relationships with clinical sites & trial personnel
  • Oversee and track patient recruitment
  • Ensure timely collection, documentation, and reporting of adverse events (AEs) and serious adverse events (SAEs) and collaborate in the submission of reports to regulatory authorities
  • Ensure the Trial Master File (TMF) is maintained and up to date
  • Ensure the CTT, CRO, and other vendors operate in a constant state of inspection readiness
  • Collaborate with Quality to ensure quality oversight of assigned trials utilizing available tools
  • Provides support during audits & inspections for assigned trials
  • The CTM will participate in activities other than trial-specific which include, but are not limited to: Provide feedback on the performance of cross-functional CTT members
  • Assist with onboarding new CTMs
  • Embrace innovation
  • Recognize non-value-added activities and propose opportunities for improvement
  • Share best practices & learnings
  • Provide input to procedures, SOPs, WIs, and related documents
  • Contribute to process initiatives within Trial Operations
  • Contribute to cross-functional improvement workstreams

 

Requirements:

  • Leadership qualities and ability to establish good and effective internal and external working relationships and communication
  • Good interpersonal skills
  • Good organizational skills to manage multiple varied tasks and prioritize workload
  • Problem-solving skills with ability to identify and resolve issues, identify and mitigate risks
  • Able to maintain a holistic cross-functional view while diving into details as needed
  • Good written and verbal communication skills, acting globally in a culturally diverse dynamic team
  • Knowledge of ICH-GCP and other applicable regulations to successfully execute clinical trials
  • Experience with tools and systems for managing clinical studies (MS Project, CTMS, TMF, IWRS, e COA, e CRF databases, etc)
  • Bachelor's degree or University degree – medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary, etc.) or equivalent by experience
  • Minimum of 4 years experience in global Clinical Trial Management roles Biotech experience is a plus
  • Rare disease, Auto-immune, and/or oncology clinical trial background is a plus

 

About Us:

Thermo Fisher Scientific is an inclusive employer and a member of my Gwork – the largest global platform for the LGBTQ+ business community.

 

  • Clinical Trials Lead Programmer

    4 dni temu

    Poland MyGwork Pełny etat

    About the JobThis is an exciting opportunity to join our team as a Clinical Trials Lead Programmer.As a key member of our programming team, you will be responsible for overseeing the statistical and programming aspects of multiple projects, acting as the lead programmer, project lead, or project oversight lead for a client/asset.You will play a crucial role...

  • Medical Director

    3 dni temu

    Poland MyGwork Pełny etat

    About the RoleAs a Medical Director at Thermo Fisher Scientific, you will play a crucial role in providing medical support and guidance for clinical trials and safety evaluation within the PPD Pharmacovigilance department.Key ResponsibilitiesProvide medical leadership to study teams, including creating clinical trial protocols and implementing the latest...

  • Quality Management Specialist

    4 dni temu

    Poland MyGwork Pełny etat

    Job Title: Quality Management SpecialistJob Summary: We are seeking a highly skilled Quality Management Specialist to lead and subject matter expert on the operational quality management framework within assigned clinical research sites in the applicable geographic region.Key Responsibilities:Ensure quality focus and provide support to the site Dyad leaders...

  • Clinical Research Associate II

    3 dni temu

    Poland MyGwork Pełny etat

    About the RoleClinical Research Associate II plays a key role in managing clinical trials according to the protocol and international standards. The ideal candidate will have a solid understanding of clinical trial design, execution, and operations, as well as expertise in communication and people management.ResponsibilitiesManagement of clinical trials...

  • Clinical Quality Compliance Lead

    3 dni temu

    Poland MyGwork Pełny etat

    Job Title: Clinical Quality Compliance LeadJob Description:This role is with ICON plc, a company that values diversity and inclusion, and a member of MyGwork, the largest global platform for the LGBTQ+ business community. As a Clinical Quality Compliance Lead, you will be joining the world's largest and most comprehensive clinical research organization,...

  • Clinical Supplies Professional

    3 dni temu

    Poland MyGwork Pełny etat

    Unlock Your Potential as a Clinical Supplies ProfessionalAre you passionate about ensuring seamless supply chain operations for global clinical trials? Do you have a keen eye for detail and a knack for problem-solving? As a Clinical Supplies Professional at Thermo Fisher Scientific, you will play a vital role in supporting the success of our clinical trials...

  • Senior Manager

    4 dni temu

    Poland MyGwork Pełny etat

    About the RoleThis position is with Thermo Fisher Scientific, an inclusive employer and a member of MyGwork, the largest global platform for the LGBTQ+ business community.Please do not contact the recruiter directly.Work Schedule Standard (Mon-Fri)Environmental Conditions OfficeAt Thermo Fisher Scientific, you'll discover meaningful work that makes a...

  • Clinical Research Associate

    4 dni temu

    Poland MyGwork Pełny etat

    Job DescriptionThis is a unique opportunity to work with Thermo Fisher Scientific, a leading company in the clinical research industry. As a Clinical Research Associate, you will be responsible for ensuring that clinical trials are conducted in accordance with regulatory requirements and good clinical practices (GCPs).Key Responsibilities:Monitoring and Site...

  • Clinical Data Management Specialist

    3 dni temu

    Poland MyGwork Pełny etat

    About the Role:We are seeking a skilled Clinical Data Management Specialist to join our team at ICON plc, an inclusive employer and a member of the Gwork community, the largest global platform for the LGBTQ+ business community.This role involves performing ongoing data review, including reconciliation of third-party data streams and serious adverse event...

  • Clinical Research Associate

    4 dni temu

    Poland MyGwork Pełny etat

    Job DescriptionThis role is with Thermo Fisher Scientific, an inclusive employer and a member of MyGwork – the largest global platform for the LGBTQ+ business community.Please do not contact the recruiter directly.Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job DescriptionMain Responsibilities:Ensure Protocol Compliance: Conduct remote...

  • Senior Clinical Data Science Lead

    3 dni temu

    Poland MyGwork Pełny etat

    Job Title: Senior Clinical Data Science LeadThis position is with ICON plc, a company that values inclusivity and diversity, and a member of MyGwork, the largest global platform for the LGBTQ+ business community.Please note that candidates should not contact the recruiter directly.As a Senior Clinical Data Science Lead, you will be part of the world's...

  • Clinical Project Lead

    10 godzin temu

    Poland MyGwork Pełny etat

    **Project Overview**Thermo Fisher Scientific is seeking a skilled Project Manager to join our Global Clinical Supplies Team in the EMEA region. This role will be responsible for managing full supply chain oversight for complex global clinical trials, ensuring project/study activities are in compliance with company and client requirements, and acting as a...

  • Global Trade Compliance Specialist

    4 dni temu

    Poland MyGwork Pełny etat

    Job Title: Associate Trade Compliance ManagerJob Summary: We are seeking a highly skilled Associate Trade Compliance Manager to join our Global Clinical Supplies Team. The successful candidate will be responsible for developing and implementing trade compliance plans for our clinical trials, ensuring seamless communication between internal departments and...

  • Medical Director Operations Poland

    4 dni temu

    Poland MyGwork Pełny etat

    Job Title: Dir Med OperationsThis role is with Thermo Fisher Scientific, an inclusive employer and a member of the largest global platform for the LGBTQ+ business community.Please do not contact the recruiter directly.Job Description: At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale.We provide our...

  • Site Contract Negotiator

    3 dni temu

    Poland MyGwork Pełny etat

    Site Contract Specialist RoleThis job opportunity is with Thermo Fisher Scientific, an inclusive employer and a member of MyGwork – the largest global platform for the LGBTQ+ business community.Please do not contact the recruiter directly.Job Description:At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global...

  • Country Regulatory Specialist

    4 dni temu

    Poland MyGwork Pełny etat

    Job Description:This role is with Thermo Fisher Scientific, an inclusive employer and a member of the global LGBTQ+ business community.Please note that you should not contact the recruiter directly.Work Schedule and Environment:Standard (Monday to Friday)Office Job DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that has a positive...

  • Senior Medical Director of Pharmacovigilance

    3 dni temu

    Poland MyGwork Pełny etat

    Unlock the Future of HealthcareAt Thermo Fisher Scientific, we're on a mission to make the world healthier, cleaner, and safer. As a Senior Medical Director, you'll play a crucial role in leading our Pharmacovigilance team, ensuring the highest standards of clinical research and development.About the RoleAs a seasoned medical leader, you'll be responsible...

  • Medical Project Coordinator, EMEA Operations

    4 dni temu

    Poland MyGwork Pełny etat

    Job SummaryThis role is with Thermo Fisher Scientific, an inclusive employer and a member of MyGwork – the largest global platform for the LGBTQ+ business community.Please note that direct contact with the recruiter should be avoided.Job DescriptionSummarized Purpose: Manage and coordinate medical projects for one or more programs in collaboration with...

  • Medical Director Position

    3 dni temu

    Poland MyGwork Pełny etat

    Role SummaryThis role is an exciting opportunity to work with Thermo Fisher Scientific, an inclusive employer and a member of the global LGBTQ+ business community, MyGwork.Please note that you should not contact the recruiter directly.Work Schedule and Environmental Conditions: Standard (Monday to Friday) in an office setting.Job Description: At Thermo...

  • Senior Account Director for Patient Recruitment Solutions

    4 dni temu

    Poland MyGwork Pełny etat

    About the RoleThis is an exciting opportunity to secure and retain business for PPD through professional, consultative, proactive sales activities directed at decision-makers and decision influencers at existing and new clinical sponsors.Key ResponsibilitiesPosition PPD as a primary or preferred provider for all patient recruitment services and support...