VACCINES – Clinical Study Manager Remote Based in the United States or Canada ICON plc is a global provider of healthcare intelligence and clinical research. We promote clinical research from molecule to medicine by delivering outsourced services to pharmaceutical, biotechnology, medical device, and government and public health organizations.
- ID
- 2022-87849
VACCINES – Clinical Study Manager Remote Based in the United States or Canada
We contribute to speed the development of pharmaceuticals and devices that save lives and improve quality of life by putting our patients at the center of everything we do.
Our biggest asset is our people, who are at the heart of our culture and the driving force behind our success. ICON employees are driven by a desire to achieve and a commitment to excellence in everything they do.
Responsibilities
So, what are your plans?
As a Clinical Study Manager, you’ll play a critical role in trial delivery and compound development for the worldwide R&D group, providing leadership and driving clinical trial choices. The CSM is in charge of leading and managing the operational implementation of country feasibility, planning, and delivery of R&D Phase I-IV clinical studies in all therapeutic areas. The CSM is the operational point of contact between the Central Study Team and the study’s in-country staff.
Works in an environment that is always changing, both internally and externally, with new processes and systems, and the CSM must be able to adapt to these changes quickly and efficiently. Flexible and adaptable, with the ability to evolve in a changing and difficult situation.
Excellent leadership qualities, encouraging others’ enthusiasm and empowerment in order to achieve individual, team, and corporate goals.
Demonstrates a thorough understanding of clinical trials, medication development, sample management, and other quality-related activities.
Strong project management attitude, as well as demonstrated ability to collaborate and lead in a matrix team setting with both internal and external partners.
Capable of representing external medical investigators and other external clinical site employees, institutional review boards, and other stakeholders, including the capacity to respond to complex queries
Capable of working effectively in a local area while also collaborating extensively with members of the central team who are located across the country. Ability to work efficiently from a distance.
In a local setting, able to create and manage priorities and performance targets.
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Team objectives are effectively planned, communicated, coordinated, and facilitated.
Strong knowledge of country-specific rules, ICH-GCP guidelines, and published standards
As required, available and willing to travel for project-related activities (e.g. Investigator and Monitors). Attendance at a meeting.
In accordance with basic values and actions, serves as a role model.
Capable of comprehending the impact of technology on studies and of using/developing computer skills while using systems/software appropriately.
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Demonstrates strategic, analytical, and conceptual thinking.
Problem-solving and conflict-resolution abilities are strong.
Demonstrates good written and verbal communication abilities in English, as well as proven bargaining skills.
Flexible and quick to learn.
Exceptional computing skills also added advantages
Responsible for high-quality study execution/delivery within nation, as outlined by protocol and within agreed-upon schedules and budgets; overall project management of research operations.
With minimal supervision:
May offer suggestions for the study’s concept, procedure, and logistics, as well as coordinate additional expert local contributions.
Examine the study’s suitability for the local area.
Assesses the feasibility of a country or site.
Leads the selection of sites across the country and is responsible for their performance.
Assists in the creation and maintenance of a country study plan and projection, including budgets, resource estimates, milestones, timeframes, quality, and risk management.
Selects and manages local vendors in accordance with local practices and the study’s overall resourcing plan; responsible for vendor management, which includes oversight, agreements, payments, communications, and issue resolution.
Responsible for managing clinical trial recruiting in compliance with relevant country commitments, including contingency planning.
Responsible for the formulation and maintenance of study budgets (budget updates, expenditures, and site payments across a study) as well as accrual reporting to the finance department.
Oversight:
Develops local recruitment and other site support materials; manages the preparation of important study documentation, plans, and manuals according to local standards (Examples include a monitoring strategy, a local informed consent form, import/export licenses, and so on.)
Ensures the establishment of a nation / site-level study risk assessment in order to proactively identify areas at risk, develop a mitigation plan, and communicate with management and study teams both locally and worldwide.
Responsible for filing or cooperating with the ethics committee/IRB (as per local regulations and LOC standard practice). In some situations, the Regulatory Authority applications and approvals may also fall under their purview.
As needed, arranges for correct translations of crucial study documentation into local language.
Supports/develops/negotiates Clinical Trial Agreements with investigational sites (depending on local practices), providing legal input if necessary.
Ensures that necessary supplies are on hand at all times and keeps track of local supply inventories.
Ensures in-country study oversight: coordinates local internal and external operational activities; maintains clear visibility into site progress and issues; reviews in-country protocol deviations; metrics; manages in-country study communications; ensures appropriate issue escalation and follow-through within and above country; effectively communicates status/issues to central team; ensures monitoring plan is followed
Establish strong working ties with crucial partners, such as local medical personnel.
Ensures that in-country personnel and investigator locations receive adequate training; arranges and provides operational parts of local study meetings, such as investigator meetings, monitor meetings, and local training.UNIVERSITY OF CALABAR POST UTME 2021/2022
Assume adequate business management monitoring activities to ensure the quality and integrity of clinical trials done in the LOC.
Provides input towards LOC and site assessment/audit proposals, and delivers country response and follow-up to assessment/audit reports.
Responsible for defining and reviewing in-country study monitoring tracking systems, as well as for monitoring important risk and performance indicators and other data. Examine all study databases for completeness.
Increases the priority of resourcing concerns to ensure that in-country study activities are adequately funded.
Ensures effective communication with sites, such as timely notification of protocol changes.
Within specified timescales, reviews and approves Monitoring Visit Reports (MVRs) for their study(s) to gain an overview of current site status.
Assists in the continuing management and reporting of study-specific safety issues, as well as the handling of safety reports, if needed (including SAE reporting).
Ensures that assigned studies are conducted in accordance with all applicable rules, ICH/GCP, and established standards in the nation.
Examines Sponsor Study Records for completeness and accuracy.
Co-ordinates / participates in learning debriefings at the end of a study / program and identifies areas for improvement.
Acquires and maintains therapeutic area and product specific information, study protocol training, and all study-related tasks for the selected therapy area. Participate in relevant training courses on a regular basis to develop your personal and professional abilities.
Maintain current understanding of ICH GCP, written standards, and attend necessary training sessions.
Interacting and collaborating with country study professionals is required.
Requirement to interact and collaborate successfully with medical staff/physicians/scientists who are often senior in their profession, while remaining cognizant of their position in the medical and/or research communities.
Interactions with important partners such as ethical committees, pharmacies, and vendors
Qualifications
What do you require?
Education:
A licensed health-care practitioner, such as a registered nurse, with a bachelor’s degree or international equivalent in a clinical, science, or health-related field from an approved university is recommended.
Requirements
Clinical research experience of 3+ years is necessary.
Experience with monitoring for at least 2 years is preferred.
Fluency in English (reading, writing, and speaking) is necessary; fluency in the host country’s language is also required.Study Work and Live in a Foreign Country
Working at ICON Has Its Advantages: Our success is dependent on the expertise, capabilities, and quality of our people. That’s why we’re dedicated to fostering a culture of continuous learning among our employees, one in which we push you with interesting work and where every experience contributes to your professional progress.
Our goal at ICON is to give you with a comprehensive and competitive overall compensation plan that includes not only a high level of base pay, but also a variety of variable pay and recognition programs. Furthermore, our best-in-class employee benefits, supporting policies, and well-being initiatives are designed to help you and your family at every stage of your career – now and in the future.
ICON, including its subsidiaries, is an equal opportunity and inclusive company committed to delivering a harassment-free workplace. Without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status, all qualified applicants shall get equal consideration for employment.
If you require a reasonable accommodation for any portion of the application process or to perform the essential tasks of a position due to a medical condition or disability, please let us know.
PRA Health Sciences was published ten days ago.
Skills required
Clinical research experience of 3+ years is necessary.
Experience with monitoring for at least two years is a plus.
Fluency in English (reading, writing, and speaking) is necessary, as is proficiency in the host country’s language.
Working at ICON has several advantages. Our success is based on our people’s expertise, abilities, and quality. That’s why we’re dedicated to fostering a culture of continuous learning among our employees, one in which you’ll be challenged with interesting work and where every experience will contribute to your professional growth.
At ICON, we strive to give you with a comprehensive and competitive total compensation plan that includes not just a competitive base salary, but also a variety of variable pay and recognition programs. Furthermore, our best-in-class employee benefits, supporting policies, and wellness initiatives are designed to help you and your family at every stage of your career, both now and in the future.
ICON, including its subsidiaries, is committed to delivering a discrimination-free and harassment-free workplace. Regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status, all qualified applicants shall be given equal consideration for employment.
Please let us know if you require a reasonable accommodation as a result of a medical condition or disability for any aspect of the application process or to perform the essential tasks of a position. VACCINES – Clinical Study Manager Remote Based in the United States or Canada