Job Closed

This listing is no longer active.

Clinical Trial Manager

Clinical ResearchClinical ResearchFull TimeRemoteSeniorTeam 10,001+Since 1990H1B No SponsorCompany SiteLinkedIn

Location

Brazil

Posted

73 days ago

Salary

0

Seniority

Senior

Bachelor DegreeEnglish

Job Description

Clinical Trial Manager

ICON plc

• Assisting project managers in the planning, execution, and monitoring of clinical trials. • Coordinating study activities, including site selection, patient recruitment, and data collection. • Supporting the development of study protocols, case report forms, and other study-related documents. • Participating in data analysis and interpretation to support decision-making and regulatory submissions. • Collaborating with cross-functional teams to ensure project milestones are met and deliverables are achieved.

Job Requirements

  • Bachelor's degree in a scientific or related field; advanced degree preferred.
  • Experience with global project management in clinical research
  • Strong organizational and multitasking skills.
  • Excellent communication and interpersonal skills.
  • Ability to work effectively in a fast-paced and team-oriented environment.
  • Fluent English

Benefits

  • 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.

Related Categories

Related Job Pages

More Clinical Research Jobs

Rho logo

Senior Biostatistician

Rho

Experience, Rho. A global full-service CRO.

OtherRemoteTeam 501-1,000Since 1984H1B Sponsor

Join us in redefining what it means to work for a CRO. Working at Rho, you’ll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity’s biggest challenges.  At Rho, we’re committed to you just as you’re committed to us. You’ll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career. With a collaborative team of smart, talented, and positive people, you’ll be celebrated and respected for your expertise and given the freedom to think creatively, challenge the norm, and problem-solve.   Currently, we at Rho are seeking a Senior Biostatistician for our Federal Research Team to work 100% remote on a permanent basis.  As a Senior Biostatistician, you will have the opportunity to lead statistical analysis activities for clinical research projects, maintaining a steady, open dialogue regarding study execution as it relates to timelines, data quality, and interpretation of the results.  Rho's team-oriented environment requires you to have open communication skills and the ability to collaborate closely as a member of a cross-functional study team. Rho's high quality standards require careful attention to accuracy and details. Because Rho recognizes great people are our most important asset, we attract and retain the best and brightest.   Why Rho? - The foundation of our organization was built on Biometrics, and it continues to be a thriving focal point for our business with strong employee tenure and stability. - We are large enough for strong stability, but small enough for you to have strong visibility and exposure to grow your career! - Support and collaboration is everywhere – from the top down. You have plenty of artillery to be successful here - It’s fun and vibrant – our culture is unbeatable - Great benefits, time off and 2 promotion cycles per year! - Lastly, we do great work and our studies are properly staffed, that makes for very happy people! These are just some of the reasons Rho has consistently been thought of as one of the CRO industry's best places to work for the past 38 years! Our Biometrics team will tell you, joining Rho has been one of their best career moves in terms of contentment, financial rewards and career growth, which is why we have such stability in the group!    - Function as statistical lead on complex clinical trials, from development through closeout. - Design scientifically sound clinical research projects, demonstrating understanding of all key design components (e.g., defining study objectives, study design and plan, study populations, treatment regimens as well as determining sample size requirements). - Author statistical sections of study documents (e.g. protocols and SAPs). - Perform various types of statistical analyses of clinical research data (e.g., demographic and other baseline characteristics, measurements of treatment compliance, efficacy evaluation, safety evaluation, pharmacokinetic evaluation, and interim analysis). - Utilize statistical software programs (e.g., SAS, R) to implement advanced statistical methodologies (e.g., longitudinal data analysis, survival analysis, Poisson regression, imputation methodologies and analyses with missing data) and verify underlying distributional assumptions. - Lead the creation of data documentation components of TMFs and regulatory submissions. - Investigate novel approaches (e.g., new applications of adaptive design) for designing and analyzing clinical research projects and make strategic decisions and recommendations accordingly. - Communicate analysis results and relevance to sponsor or investigators. - Ensure effective, accurate and timely communication of key issues and progress to the team and Sr. Management. - Exhibit the expertise to do tasks independently and to oversee, train and mentor others in task completion. - Participate in the Biostatistics community at Rho by contributing to internal initiatives and standard operating procedures for the administration and support of clinical trials. - Involvement with budgets, proposals, and other business development activities. - Create integrated databases for submission to regulatory bodies. - Represent sponsors at FDA meetings (type A, B, and C). - Respond to information requests or other queries from regulatory bodies. - Author relevant sections of briefing books and briefing packages to support FDA interactions. - Advise and consult with sponsors regarding FDA data analytical and filing requirements.

United States
$115K - $135K / year
Job Closed
Full TimeRemoteTeam 10,001+Since 1990H1B No Sponsor

Clinical Research Physician ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development Job Advert Posting At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development. That’s our vision. We’re driven by it. And we need talented people who share it. If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry Clinical Research Physician - Provide medical data review support to ICON Project Teams in order to ensure that projects of all phases (1-4) are conducted according to the highest ethical principles and medical standards, in accordance with good pharmacovigilance practices and in compliance with applicable legal and regulatory standards. - Provide medical leadership on projects, when assigned. JOB FUNCTIONS/RESPONSIBILITIES: - Serve as medical team leader on assigned projects, - Ensure provision of all contracted activities and identification of out of scope activities on projects assigned - Medical review of clinical trial data, including review of Laboratory alerts, Electrocardiogram (ECG) alerts, data from eCRF/ EDC (listing review/ Patient profile review), Eligibility review, Identify protocol deviations, coding review and preparation of Medical Monitoring Reports as per requirement - Provide all necessary medical support functions as defined by project specific contractual obligations which will include, but not be limited to, the following: - Medical information source - Ongoing training for project teams in therapeutic areas as requested - Review of study documentation (protocol, CRF. etc.) - Contribute to investigator meeting presentations - Ongoing safety review of individual patient laboratory reports generated by central laboratories - CRF safety review - Contribute any necessary medical input into integrated clinical and statistical reports - Assist in making presentations to potential clients when appropriate - Demonstrate a thorough understanding of ICON Standard Operating Procedures (SOPs) and ensure that all activities are conducted in accordance with current SOPs - Demonstrate a thorough understanding of applicable regulatory standards in the country where clinical studies are to be conducted and ensure that all activities are conducted in compliance with current regulations - Represent ICON Medical Affairs at teleconferences and meetings - Liaise with Sponsors regarding medical issues and medical consultation - Ensure quality of medical deliverables in accordance with project plans and ICON Standards - Keep the person to whom the Clinical Research Physician reports informed of any issues within the department which require attention QUALIFICATIONS/EXPERIENCE REQUIRED: - To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions - Medical degree and broad based post graduate clinical experience - Preferably 1-2 years’ experience in a relevant role, ability to medically evaluate clinical data, and good analytical skills - Proficiency in English, Good oral and written communication skills - Ability and willingness to travel on an as-need basis - Excellent presentation skills - Good computer skills (MS: Outlook, Word, Excel) Benefits of Working in ICON: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent. We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours. We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead. But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change. ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. #LI-CL1 What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: - 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Oman + 1 moreAll locations: Oman | Romania
Full TimeRemoteTeam 10,001+H1B No Sponsor

Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers’ toughest challenges. While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ applies to any personal information you submit. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Job Description: 3M Health Care ist jetzt Solventum Bei Solventum ermöglichen wir eine bessere, intelligentere und sicherere Gesundheitsversorgung, um das Leben zu optimieren. Als junges Unternehmen mit einer langen Innovationstradition leisten wir Pionierarbeit für bahnbrechende Entwicklungen an der Schnittstelle von Gesundheit, Material- und Datenwissenschaft, die das Leben von Patienten zum Besseren verändern und es medizinischem Fachpersonal ermöglichen, ihr Bestes zu geben. Denn die Menschen und ihr Wohlergehen stehen im Mittelpunkt jedes wissenschaftlichen Fortschritts, den wir verfolgen. Wir arbeiten eng mit den klügsten Köpfen im Gesundheitswesen zusammen, um sicherzustellen, dass jede Lösung, die wir entwickeln, die neueste Technologie mit Mitgefühl und Empathie verbindet. Denn bei Solventum hören wir nie auf, Lösungen für Sie zu finden. Ihr Beitrag zu unserem gemeinsamen Erfolg Als Dental Clinical Specialist (m/w/*) für den Bereich Dental Solutions haben Sie die Möglichkeit, Ihr Wissen zielgerichtet einzusetzen, um unseren gemeinsamen Erfolg voranzubringen. Dabei umfasst Ihr Aufgabengebiet: - Sie sind ein Subject Matter Expert für unsere Dentalprodukte. - Sie implementieren und managen interne und externe Trainings, Kunden-Veranstaltungen und unterstützen unsere Zahnärzt*innen und Verkaufskolleg*innen bei Anwendungen unserer Produkte und Prozesse. - Darüber hinaus arbeiten Sie eng mit den Abteilungen Vertrieb, Marketing und Scientific Affairs & Education zusammen, um Geschäftswachstum zu generieren. - Ebenfalls entwickeln und managen Sie die Kommunikation mit den Key Opinion Leadern und Handelspartnern. Firmenfahrzeug Diese Position erfordert das Fahren eines Firmenfahrzeugs, was eine Überprüfung einer gültigen PKW-Fahrerlaubnis für den Kandidaten erforderlich macht. Das sind Ihre Kompetenzen Die Mindestqualifikationen dieser Rolle umfassen: - Hochschulabschluss der Zahnmedizin und Erfahrung als Zahnarzt oder eine abgeschlossene Ausbildung und Erfahrung als Zahntechniker oder Erfahrung in einem Unternehmen für Dentalprodukte - Es bereitet Ihnen Freude, Menschen zu beraten und sie von neuen Lösungen zu überzeugen - fließende Deutsch- und Englischkenntnisse - Sie können sehr gut selbständig und eigenverantwortlich arbeiten und besitzen einen ausgeprägten Team- und Netzwerkgedanken Diese weiteren Kenntnisse sind von Vorteil: - Sie haben bereits Erfahrung und Spaß beim Trainieren und Unterrichten Arbeitsort: remote Reisebereitschaft - Kann bis zu 80% der Arbeitszeit im Vertriebsgebiet betragen. Unterstützung Ihres Wohlbefindens Solventum bietet viele Programme an, die Ihnen helfen, Ihr bestes Leben flexibel zu gestalten und zu optimieren – sowohl körperlich als auch finanziell. Um eine wettbewerbsfähige Vergütung und Sozialleistungen zu gewährleisten, vergleicht sich Solventum regelmäßig mit anderen Unternehmen, die in Größe und Umfang vergleichbar sind. (*) Bei Solventum spielen Vielfalt und Inklusion eine entscheidende Rolle für Innovation. Hier werden Sie eine Kultur entdecken, die keinen ausgrenzt. Wir wertschätzen verschiedene kulturelle Hintergründe und heißen alle Bewerber, unabhängig des Geschlechts, Alters, Nationalität, Religion oder sexuellen Orientierung, herzlich willkommen! Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers. Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of @solventum.com. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains. Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly. Solventum Global Terms of Use and Privacy Statement Carefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at Solventum are conditioned on your acceptance and compliance with these terms. Please access the linked document by clicking here. Before submitting your application you will be asked to confirm your agreement with the terms.

Germany
Full TimeRemoteTeam 10,001+Since 1990H1B No Sponsor

Clinical Research Associate ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development As a CRA I at ICON, you will contribute to our clinical trial operations function, working collaboratively to deliver high-quality outcomes across our clinical programmes. What You Will Do: Your role will involve delivering clinical trial monitoring work to a high standard, working closely with your team and stakeholders. Key responsibilities include: - Working independently and actively to coordinate all activities for setting up and monitoring a study, completing accurate study status reports and maintaining study documentation - Running sponsor generated queries efficiently and taking responsibility for study cost efficiency; you will also participate in the preparation and review of study documentation and feasibility studies for new proposals as required. - Develop and maintain strong, collaborative relationships with key stakeholders, clinical investigators, and site staff. - Ensure patient safety by ensuring compliance with ICON's procedures, protocols, and regulatory requirements. Your Profile: You will bring relevant clinical trial monitoring experience, along with the following qualifications and skills. Required qualifications and experience: - University degree in medicine, science, or equivalent - Knowledge of ICH-GCP guidelines and the expertise to review and evaluate medical data - Excellent written and verbal communication in English - Good social skills enabling you to deal with queries in a timely manner - Willingness to travel as required (approximately 60%) What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: - 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Czechia
Job Closed