Clinical Operations Specialist
4 days ago
At Syneos Health, we are passionate about accelerating customer success. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
We simplify and streamline our work to make us easier to work with, and to make us easier to work for. Our employees, across 110 countries, already know what it means to be part of a company that is passionate about making a difference. Discover why over 29,000 people choose to work here.
Our Culture
- We are committed to developing our people through career development and progression, technical and therapeutic area training, peer recognition and total rewards program.
- We strive to create a culture where everyone feels like they belong. This is achieved by bringing together diversity of thoughts, backgrounds, cultures, and perspectives.
Job Responsibilities
- We are looking for someone to provide quality deliverables at the country level. The successful candidate will follow project requirements and applicable country rules, with oversight from the SSU Country Manager.
- The ideal candidate will work within forecasted submission/approval timelines and ensure compliance. They will track milestone progress in real time, identify delays, and escalate issues as necessary.
- Responsibilities include monitoring basic financial aspects of projects, hours/tasks available per contract, and escalating discrepancies in a timely fashion.
- The successful candidate will review and comply with Standard Operating Procedures (SOPs) and Work Instructions (WIs). They will keep training records updated accordingly and ensure timesheet compliance.
- They will also ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
Key Functions
- The successful candidate may be responsible for one or more of the following functions:
- Local Submissions Specialist - Follows project direction provided by the designated country start-up advisor (CSA) and SAL. May serve as a point of contact for the SAL/PM during start-up on allocated projects.
- Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required.
- May act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues. Oversees site activation end-to-end process at country/site level.
Qualifications
- An associate degree or equivalent combination of education and training is required.
- Good understanding of clinical trial process across Phases II-IV and ICH GCP is essential.
- The ideal candidate will have good organizational skills and attention to detail, with proven ability to handle multiple tasks effectively.
- Ability to take direction from multiple individuals and set priorities accordingly is necessary.
- The successful candidate will have strong communication skills, including the ability to interact effectively and appropriately with investigative site personnel.
- Demonstrated ability to work independently, as well as part of a team, is essential.
- Flexibility and willingness to adapt to a rapidly changing environment and learn/perform new functions is necessary.
- Strong computer skills, including Word, Excel, PowerPoint, Publisher, are required.
-
Clinical Operations Specialist
5 days ago
Québec, Quebec, Canada ICON Full timeCompany Overview:"]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 Global In House CRA.We prioritize diversity, inclusion & belonging in our...
-
Clinical Activation Specialist
1 day ago
Québec, Quebec, Canada Syneos Health Full timeAbout the RoleAs a Clinical Activation Specialist at Syneos Health, you will play a critical role in ensuring the timely and successful activation of clinical trial sites across various regions.Your primary responsibility will be to provide quality deliverables at the country level, adhering to project requirements and applicable country rules, with...
-
Clinical Trial Start-Up Specialist
23 hours ago
Québec, Quebec, Canada Syneos Health Full timeOverview: At Syneos Health, we're looking for an experienced Site Contract Specialist to join our team. In this role, you'll play a vital part in managing site-specific contracts, negotiating budgets, and ensuring compliance with regulatory requirements. We require candidates with expertise in contract research organizations or the pharmaceutical industry,...
-
Clinical Case Manager Specialist
4 days ago
Québec, Quebec, Canada Libertana Full timeJob Description:The Clinical Case Manager Specialist at Libertana is responsible for coordinating the clinical care of ECM Program clients. This involves identifying, organizing, and monitoring services needed by recipients, as well as assisting them in gaining access to community resources. The position primarily takes place in the...
-
Québec, Quebec, Canada Syneos Health Full timeAt Syneos Health, we are passionate about developing our people and delivering exceptional results. We're looking for a highly skilled Senior Medical Editor to join our team as a Clinical Documentation Specialist. In this role, you will be responsible for quality control review of clinical documents intended for submission to health authorities...
-
Site Contract Specialist
23 hours ago
Québec, Quebec, Canada Syneos Health Full timeJob Overview: As a Site Contract Specialist, you will play a crucial role in the clinical development process at Syneos Health. This position involves managing site-specific contracts, negotiating budgets and related documents, and ensuring compliance with regulatory requirements. If you have experience in contract research organizations or the...
-
Senior Contract Specialist
1 day ago
Québec, Quebec, Canada Syneos Health Full timeAbout the PositionWe are seeking an experienced Senior Contract Specialist to join our site operations team. As a key contributor, you will be responsible for producing site-specific contracts from country clinical trial agreement (CTA) templates. Your primary focus will be on reviewing and owning site-specific contracts, submitting proposed CTA and...
-
Clinical Research Operations Leader
1 day ago
Québec, Quebec, Canada Syneos Health Full timeAbout the Role As a Clinical Trial Manager II, you will be responsible for managing clinical trials from start to finish. This includes site selection, site initiation, and ongoing site management, as well as coordination with internal stakeholders and external partners. You will work closely with the project manager to ensure timely completion of clinical...
-
Clinical Trial Operations Manager
1 day ago
Québec, Quebec, Canada Syneos Health Full timeJob DescriptionThe Senior Clinical Trial Manager will be responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.This includes overseeing site interactions post activation through site closeout, managing patient recruitment,...
-
Research and Clinical Nursing Specialist
22 hours ago
Québec, Quebec, Canada Syneos Health Full timeAbout the Position:We are seeking a skilled and dedicated Clinical Research Nurse to join our team at Syneos Health. As a Clinical Research Nurse, you will have the opportunity to work on a range of research projects, providing clinical services to patients participating in clinical trials.Key Responsibilities:Conduct clinical research nursing...
-
Clinical Development Specialist
1 day ago
Québec, Quebec, Canada Syneos Health Full timeAbout UsSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the patient to the center of everything that we do. We...
-
Clinical Therapist
4 weeks ago
Québec, Quebec, Canada ROME GROUP Full timeThe clinical therapist works as a member of an integrated primary care team to provide outpatient counseling. The clinical therapist will provide support and treatment of a variety of behavioral health and substance use disorders within a diverse adult population. This role is within an integrated system of medical providers, the behavioral health team, and...
-
Lead Clinical Documentation Specialist
1 day ago
Québec, Quebec, Canada Syneos Health Full timeAbout Syneos Health We are a global biopharmaceutical solutions organization that has worked with 94% of all novel FDA-approved drugs, 95% of EMA-authorized products, and over 200 studies across 73,000 sites and 675,000+ trial patients. Why Join Us? We believe in developing our people through career development and progression; supportive and engaged line...
-
Clinical Counselor
7 days ago
Québec, Quebec, Canada LifeWorks Full timeCompany OverviewTelus Health is a leading health and wellness provider that empowers individuals to live their healthiest lives. We leverage our technology solutions to improve health outcomes for consumers, patients, healthcare professionals, employers, and employees.Job DescriptionAs an EAP Clinical Counselor at Telus Health, you will play a crucial role...
-
Clinical Document Specialist
4 days ago
Québec, Quebec, Canada Syneos Health Full timeAbout Syneos Health Syneos Health is a leading provider of integrated biopharmaceutical solutions, accelerating customer success through clinical development. We prioritize simplification and streamlining our work to make us easier to work with and for our employees. Our agile approach drives the delivery of therapies, improving lives globally. Discover why...
-
Biopharmaceutical Solutions Specialist
4 days ago
Québec, Quebec, Canada Syneos Health Full timeWe are seeking a highly skilled Biopharmaceutical Solutions Specialist to join our team at Syneos Health. As a key member of our regulatory affairs department, you will play a crucial role in ensuring the success of our clients' projects. Your primary responsibilities will include contributing to the preparation of regulatory submissions, managing project...
-
Global Clinical Trials Coordinator
5 days ago
Québec, Quebec, Canada ICON Full timeJob Summary:A highly skilled professional with experience in clinical operations is sought by ICON to coordinate global clinical trials. The ideal candidate will have a strong understanding of trial management, excellent organizational skills, and the ability to work independently in a dynamic environment. As a Global In-House CRA, you will play a vital role...
-
Plant Operations Specialist
4 days ago
Québec, Quebec, Canada Tekdata Metal Solutions inc. Full timeWe are seeking a highly skilled Plant Operations Specialist to join our team at Tekdata Metal Solutions inc. This is an exceptional opportunity for someone who thrives in a dynamic and fast-paced environment.About the RoleThe Assistant Manufacturing Director will play a critical role in supporting the management team by coordinating plant operations and...
-
Security Operations Specialist
3 days ago
Québec, Quebec, Canada Lightspeed Full timeCogir Immobilier, a leading real estate management company, seeks a seasoned Security Operations Specialist to support its payroll department.Key Responsibilities:Prepare and reconcile human resources and payroll dataCoordinate accounting activities to ensure timely and accurate account balancingManage check processing and reconciliation with government...
-
Dispatch Operations Specialist
7 days ago
Québec, Quebec, Canada Navada Full timeAre you an enthusiastic and motivated individual looking for a long-term opportunity? Do you have excellent communication skills and the ability to work under pressure? If so, we invite you to apply for the Dispatch Operations Specialist position at Navada.Job ResponsibilitiesThe successful candidate will be responsible for:Supporting customers during...