Clinical Trial Manager

at  Precision Medicine Group

București, Municipiul București, Romania -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate29 Jul, 2024Not Specified04 May, 2024N/ABiomarkers,Oncology,Color,International Travel,Ms Project,Powerpoint,Llc,Cancer,Availability,Computer Skills,Clinical Trials,ItNoNo
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Description:

We have current opportunity for an experienced Clinical Trial Manager in Europe! Join our growing team.
Precision for Medicine is a precision medicine CRO. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.
You will be the hub of central intelligence for the studies you will be managing, and will lead CRAs and oversee all clinical aspects of your study across multiple countries, ensuring timeline adherence and scope, whilst ensuring quality delivery. We encourage high-energy, dedicated professionals who enjoy a challenge, thrive in the details and flourish in dynamic environments to explore this opportunity.
We are addressing the challenges facing the research and development of novel compounds in Oncology and are dedicated to positively impacting the health and lives of patients around the world. If you take a consultative approach to trial management, proving to be a valuable partner in the trial operational delivery process, don’t miss exploring working with us.
We offer flexible location options, and remote based working. This position can be based in one of the following countries: Spain, UK, Poland, Hungary, Serbia. Romania, Slovakia.

QUALIFICATIONS:

Minimum Required:

  • Bachelor’s degree or equivalent combination of education/experience in science or health-related field, including experience in the field of oncology

Other Required:

  • Demonstrable experience leading clinical aspects of your studies across multiple countries in a CRO / Pharma or Biotech company (in a dedicated ‘clinical lead’ role).
  • Working knowledge of GCP/ICH guidelines and the clinical development process
  • Availability for domestic and international travel including overnight stays

Skills:

  • Demonstrated computer skills (MS Office, MS Project, PowerPoint) and software experience (CTMS, eTMF, EDC, IXRS)
  • Demonstrated ability to develop positive working relationships with internal and external organizations
  • Demonstrates core understanding of medical terminology and clinical trial activities as it relates to the execution of a clinical development plan

Competencies:

  • Demonstrates mastery knowledge of ICH-GCP, meaningful Precision SOPs, and regulatory guidance, as well as the ability to implement

Precision medicine is revolutionizing the attack on cancer—and we are passionate about helping you harness its power. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway.
Any data provided as a part of this application will be stored in accordance with our Privacy Policy.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com

Responsibilities:

  • Management and operational delivery of the clinical elements within a trial including site selection, start-up, enrollment management, site engagement and support, monitoring planning and execution, data cleaning activities and close-out
  • Successful execution of assigned trials and ensuring completion of trial deliverables
  • Ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned trial(s) by working in close collaboration with other functional team members
  • Mentoring and training of team members
  • Identify challenges to study timelines/deliverables and offer creative action plans to the team/sponsor
  • Lead CRAs as they establish relationships with their sites for high quality oversight of monitoring, regulatory, IP, site payment and overall site correspondence activities
  • Maintain team focus on study priorities through efficient cross-functional partnerships and effective communication to achieve the highest level of client satisfaction


REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Graduate

The field of oncology

Proficient

1

București, Romania