Centralized Study Specialist I
hace 4 semanas
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
We are seeking an experienced and highly motivated Centralized Study Specialist I to join our team. This role involves managing clinical systems, supporting study documentation, ensuring compliance, and providing leadership and mentorship to junior team members. The successful candidate will play a pivotal role in the successful execution of clinical trials and contribute to process improvement initiatives.
Key Responsibilities:
- Clinical Systems Management:
Oversee and manage clinical systems. Maintain study databases (CTMS, IWRS, EDC, etc.). Support eTMF management. - Study Coordination:
Track and follow up with CRAs on outstanding issues. Generate study-specific reports. Manage internal and external communications. Ensure training compliance for study teams. Assist in managing study payments (Site and Vendor). - Data Review:
Follow up with CRAs for resolution of outstanding issues/action items. Perform Associate Lead/Lead role for assigned projects. Draft and send study-specific reports. Collaborate with Data Management and Programming teams. Perform other data review-related tasks as instructed. - Study Support:
Generate and analyze study reports. Manage access on applicable study systems. Set up study systems for newly awarded studies. Ensure CTMS compliance. Manage project communications. Assist project teams with study support activities. - Investigator Payments:
Review EDC, contracts, and mark line items for payment. Generate cover letters or Proforma invoices and payment batches. Perform invoice quality checks and prepare GIA. Coordinate with CTL and PM for approvals. Process Out of Pocket and Pass-Through Expense Invoices. Perform payment reconciliation. Mentor and train new team members. Perform quality checks on team deliverables. - General Responsibilities:
Follow all departmental Standard Operating Procedures and Work Instructions. Complete required trainings on time. Ensure quality and productivity in day-to-day tasks. Manage project and technical documentation appropriately. Provide administrative and technical support to internal departments. Ensure quality of completed work through checks. Timely escalate and resolve issues. Execute high-quality, timely monitoring and reporting plans. Support the implementation of new monitoring tools. Track and report metrics as required by management. Identify and support process improvement opportunities. Assist in document management and preparation of new investigator submission packages. Support study team for contracts and budget activities for investigative sites. Assist with site start-up activities. Review, support, manage, or assist in managing site clinical trial contracts.
Qualifications (Minimum Required):
- Education:
University/College Degree in Life Sciences or a related field, or certification in an allied health profession from an accredited institution (e.g., Nursing certification, Medical or Laboratory Technology). - Experience:
2-3 years of work experience in clinical research. Strong working knowledge of ICH-GCP guidelines and other applicable regulations. Relevant and equivalent experience may be considered in lieu of educational requirements. - Skills:
Demonstrated ability to plan, prioritize, organize, and communicate effectively. Attention to detail and high-quality work delivery. Strong interpersonal skills and ability to work collaboratively. Ability to influence others and facilitate meetings. Experience in leading process improvement initiatives. Ability to mentor and train others.
If you are passionate about clinical research and have the required qualifications and experience, we encourage you to apply. Join us in our mission to advance healthcare and improve lives.
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.
#J-18808-Ljbffr-
Senior Centralized Study Specialist
hace 4 semanas
Bogotá, Colombia INGEPSY A tiempo completoAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Global Clinical Operations Specialist
hace 4 semanas
Bogotá, Bogotá D.E., Colombia Ingepsy A tiempo completoCompany Overview:Ingepsy, a leading global contract research organization (CRO), is dedicated to advancing healthcare and improving lives through its commitment to scientific rigor and clinical development expertise.We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development solutions across more than 20...
-
Payment Specialist I
hace 4 meses
Bogotá, Cundinamarca, Colombia Fortrea A tiempo completoAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Systems Alert Specialist I
hace 1 mes
Bogotá, Colombia Sagan A tiempo completoJob Title: Systems Alert Specialist ILocation: Remote (CST Time zone)Salary Range: up to 5000 USDWork Schedule: Monday - Friday, 8:00 AM to 5:00 PM (CST)NOTE: INDEPENDENT CONTRACTOR POSITIONCompany Overview:Sagan is an exclusive membership community for top executives, founders, and CEOs seeking to hire and maximize the impact of international talent. We...
-
Clinical Research Project Manager
hace 4 semanas
Bogotá, Bogotá D.E., Colombia Ingepsy A tiempo completoJob OverviewIngepsy is a leading global contract research organization (CRO) with a strong passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic...
-
Insurance Coverage Specialist
hace 4 semanas
Bogotá, Bogotá D.E., Colombia Bruntwork A tiempo completoAbout BruntworkBruntwork is a dynamic organization dedicated to delivering exceptional patient care services. As a leading provider of healthcare solutions, we strive to create a supportive environment that fosters growth and excellence in our team members.Salary InformationThe estimated annual salary for this position is $60,000-$80,000, depending on...
-
Document Control Specialist I
hace 5 días
Bogotá, Bogotá D.E., Colombia Aecom A tiempo completoAECOM Vacancy: Document Control Specialist IAre you a detail-oriented professional with experience in document control and management? We have an exciting opportunity for a Document Control Specialist I to join our team in Bogota, Colombia.About the Role:We are seeking a highly organized and efficient individual to manage documents related to projects. This...
-
Global Markets Specialist
hace 4 meses
Bogotá, Colombia Michael Page Colombia A tiempo completoAcerca de nuestro cliente Investment sector Descripción Reporting to the Treasury Manager, the Global Markets Specialist will: Study and analyze the managers to whom the FMM has exposure through the assets of the Global Endowment. Manage the asset classes that make up the Global Endowment, aiming to generate alpha relative to their benchmarks...
-
Database Specialist Lead
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Scotiabank A tiempo completoJob SummaryWe are seeking a skilled Database Specialist Lead to join our team at Scotiabank in Bogota, Colombia. In this role, you will be responsible for ensuring the smooth operation of our database services and supporting the development and maintenance of our systems.About ScotiabankScotiabank is a leading financial institution with a strong presence in...
-
Operations Efficiency Specialist
hace 16 horas
Bogotá, Bogotá D.E., Colombia Buscojobs Colombia A tiempo completoAnthology, the leading EdTech ecosystem, is seeking a skilled Operations Efficiency Specialist to join our Student Success team.We believe in the power of diversity and inclusion, and we are committed to making it a foundational part of our hiring practices and company culture.The ideal candidate will have at least 1 year of contact center experience, a high...
-
Associate Product Specialist
hace 3 meses
Bogotá, Cundinamarca, Colombia Mastercard A tiempo completoOur Purpose We work to connect and power an inclusive, digital economy that benefits everyone, everywhere by making transactions safe, simple, smart and accessible. Using secure data and networks, partnerships and passion, our innovations and solutions help individuals, financial institutions, governments and businesses realize their greatest potential. Our...
-
Systems Alert Specialist I
hace 4 semanas
Bogotá, Colombia INGEPSY A tiempo completoWork Schedule : Monday - Friday, 8 : 00 AM to 5 : 00 PM (CST) NOTE : INDEPENDENT CONTRACTOR POSITION Company Overview : Sagan is an exclusive membership community for top executives, founders, and CEOs seeking to hire and maximize the impact of international talent. We bridge the gap between global talent and US-based businesses, connecting...
-
Dedicated Desktop Support Specialist
hace 2 semanas
Bogotá, Bogotá D.E., Colombia Sutherland A tiempo completoCompany Overview: Sutherland is a global leader in AI, automation, cloud engineering, and advanced analytics. We empower business leaders with market-leading technology and process excellence.Job Description: We're seeking a skilled desktop support specialist to join our team!Salary: $65,000 - $80,000 per annum, depending on location and experience.Job...
-
Digital Influence Marketing Specialist
hace 1 día
Bogotá, Bogotá D.E., Colombia Beiersdorf A tiempo completoJob Description">About UsBeiersdorf is a leading global skin care company, committed to helping people feel good about their skin. With a rich history spanning over 140 years, we have developed innovative products for renowned brands such as NIVEA, Eucerin, La Prairie, Hansaplast, and Labello.">Our PurposeWe live by our purpose, WE CARE BEYOND SKIN, taking...
-
Site Management Associate
hace 20 horas
Bogotá, Colombia ENGINEERINGUK A tiempo completoYou will need to login before you can apply for a job. Site Management Associate (Senior and level I) 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...
-
IT Security Specialist I
hace 1 día
Bogotá, Colombia Capgemini A tiempo completoCapgemini is seeking a highly motivated and detail-oriented Information Security Specialist I to join our team to work for a top 10 US Insurance Carrier. This role will be responsible for having experience with firewalls and a strong knowledge of network infrastructure , routing , switching , and network security best practices ....
-
Product Operations Specialist Lead
hace 5 días
Bogotá, Bogotá D.E., Colombia Bruntwork A tiempo completo**Job Description for Product Operations Specialist at Bruntwork**We are looking for a highly skilled Product Operations Specialist to join our team at Bruntwork. As a key member of our product operations team, you will play a crucial role in supporting the growth and success of our product.**About the Role**The ideal candidate will have strong analytical,...
-
Senior Tmf Specialist
hace 3 semanas
Bogotá, Colombia Emmes Global A tiempo completoOverview: **Senior TMF Specialist** **LATAM Remote** Emmes Group: Building a better future for us all. Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers...
-
Medical Communication Specialist
hace 4 semanas
Bogotá, Bogotá D.E., Colombia Ingepsy A tiempo completoAbout the Role:">We are seeking a skilled Medical Communication Specialist to join our team.Your Key Responsibilities:">Facilitate clear and accurate communication between patients and healthcare professionals over the phone in Spanish and English.Demonstrate full command of medical terminology and vocabulary in both languages.Maintain confidentiality and...
-
Claims Dispute Specialist
hace 7 días
Bogotá, Bogotá D.E., Colombia Bruntwork A tiempo completoJob Title: Claims Dispute Specialist\About Us: At Bruntwork, we are committed to providing exceptional customer service and ensuring timely resolution of claims disputes. We are seeking a highly skilled Claims Dispute Specialist to join our team.\Estimated Salary: $60,000 - $80,000 per year (based on industry standards and location)\Job Description: The...
