Senior Clinical Trial Coordinator

vor 1 Woche

Munich, Bayern, Deutschland Alira Health Vollzeit

Are you being referred to one of our roles by a connection in Alira Health? If so, please apply using the referral link emailed to you.

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

Job Description Summary

Job Description

THE SENIOR CLINICAL TRIAL COORDINATOR ROLE

The Senior Clinical Trial Coordinator assists the clinical research team to ensure that the study is conducted in accordance with GCP, all relevant SOPs, the protocol and in respect of the budget and timelines. They will collaborate with the Study Start-Up team. and ensures the start-up activities are performed both with quality and on time. They will oversee and mentor junior Clinical Trial Coordinators and junior team members as needed. 

KEY RESPONSABILITIES

  • Responsible (under PM oversight and in conjunction with the Study Start-Up Team) for start-up activities, including Ethic and Regulatory submission (at national and international level) and sites contract negotiation.

  • Responsible for ISF preparation and TMF set up and maintenance (under PM oversight).

  • Training and support of junior CTCs for use of tools, e.g. CTMS.

  • Maintains relationship with ECs and CA  for e.g device, observational, real-world evidence studies.

  • Supports in sites/vendors invoicing management and responsible to maintain an appropriate tracking if required.

  • Responsible for vendor management (under PM oversight).

  • Collaborates with the preparation of weekly/monthly and ad hoc project reports, also updating CTMS and maintaining study-specific trackers as needed.

  • Supports with CRAs activities follow-up.

  • Supports with document translation, if required.

  • Participates in internal, client/sponsor, scientific, and other meetings as required; participates to audit.

  • Performs additional duties as assigned.

DESIRED QUALIFICATION & EXPERIENCE

  • Graduation in scientific/health field

  • Previous experience in clinical research (in CROs, Pharma or academy/hospital experience)

  • Good knowledge of ICH GCP and appropriate regulations

  • Good knowledge of Clinical Research and Regulatory/Ethical requirements

TECHNICAL COMPETENCES & SOFT SKILLS 

  • English, good 

  • MS Office Suite, good 

  • Professional  

  • Trustworthy

  • Quality focused; ability to be careful, thorough, and detail-oriented 

  • Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment; able to manage priorities and organize time 

  • Strong analytical skills  

  • Strong communication and interpersonal skills with customer service orientation

WORKING CONDITIONS/PHYSICAL DEMANDS 

Normal office working conditions including frequent sitting, standing, bending, twisting and computer monitor use. Occasional lifting up to 30 lbs.  

Languages

English

Education

Bachelor of Science (BS), Bachelor of Science (BS): Biology, Bachelor of Science (BS): Medicine

Contract Type

Regular

  • Clinical Trial Coordinator

    vor 1 Woche

    Munich, Bayern, Deutschland Alira Health Vollzeit

    Are you being referred to one of our roles by a connection in Alira Health? If so, please apply using the referral link emailed to you.Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and...

  • Sponsor Dedicated Clinical Trial Manager based in Munich area

    vor 1 Woche

    Munich, Bayern, Deutschland Fortrea Vollzeit

    Are you a dynamic leader passionate about driving clinical trials to success? We are looking for an experiencedClinical Trial Managerresponsible for study oversight and delivery management (time, budget, quality)from start-up to closure in Germany. In this role, you'll collaborate with sponsors, investigators and cross-functional teams to bring life-changing...

  • Head of Clinical Operations

    vor 1 Woche

    Munich, Bayern, Deutschland Meet Life Sciences Vollzeit

    We are partnering with a growing, oncology-focused biotech to appoint a Head of Clinical Operations at Senior Director or VP level. This is a critical leadership role reporting directly to the Chief Medical Officer, based in Munich with a hybrid working model (3 days on site).This position offers the opportunity to make a meaningful impact at a pivotal stage...

  • Senior Data Scientist with focus Clinical Statistics

    vor 2 Wochen

    Munich, Bayern, Deutschland Staburo GmbH Vollzeit

    Your Responsibilities Will IncludeAnalysis of project data (e.g. trial data) and data processingStatistical programming, development of reusable programs (e.g. functions, macros), data visualization, program validation, output generationSupport non-clinical / clinical development in all phases, study planning (protocol, study design), sample size, reporting,...

  • Senior Data Scientist with focus Clinical Statistics

    vor 2 Wochen

    Munich, Bayern, Deutschland Staburo Vollzeit

    Your responsibilities will include Analysis of project data (e.g. trial data) and data processing Statistical programming, development of reusable programs (e.g. functions, macros), data visualization, program validation, output generation Support non-clinical / clinical development in all phases, study planning (protocol, study design), sample size,...

  • Senior Data Scientist with focus Clinical Statistics

    vor 2 Wochen

    Munich, Bayern, Deutschland Staburo GmbH Vollzeit

    Your responsibilities will includeAnalysis of project data (e.g. trial data) and data processing Statistical programming, development of reusable programs (e.g. functions, macros), data visualization, program validation, output generation Support non-clinical / clinical development in all phases, study planning (protocol, study design), sample size,...

  • Clinical Site Contracts Lead client-based in Munich

    vor 2 Wochen

    Munich, Bayern, Deutschland Fortrea Vollzeit

    Are you ready to take your expertise in clinical contracts and budgeting to the next level? AtFortrea, we are looking for a detail-oriented and strategic professional to join our FSP team as aSite Contract Lead. In this role, you will be at the forefront of clinical trial execution, ensuring that contracts and budgets are aligned with operational goals and...

  • Lead Clinical Research Associate

    vor 1 Woche

    Munich, Bayern, Deutschland CHEManager International Vollzeit

    About This RoleTFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service Provider (FSP) solutions.TheFreelance Lead Clinical Research...

  • Clinical Research Associate based in Germany

    Vor 2 Tagen

    Munich, Bayern, Deutschland CHEManager International Vollzeit

    Be the connection between science and solutions.In this CRA position, you'll help transform complex clinical protocols into real-world results, working alongside a team that values precision, integrity, and progress. This role will offer you the opportunity to directly influence the success of global clinical trials and the delivery of innovative therapies...

  • Senior Clinical Research Associate

    vor 2 Wochen

    Munich, Bayern, Deutschland Progressive Vollzeit

    Senior Clinical Research Associate (CRA) - OnkologiePosition:Senior Clinical Research AssociateUnternehmen:Contract Research Organization (CRO)Standort:Remote/ homebasedBerichtet an:Clinical Operations Manager / ProjektleiterArt der Anstellung:VollzeitÜber die RolleAls Senior Clinical Research Associate (CRA) in der IndikationOnkologiebist du verantwortlich...