Senior Clinical Site Manager US

4 weeks ago

Raleigh, United States CareerBuilder Full time

Make your mark for patients

Maximizing site performance and site engagement in UCB conducted clinical studies. Leveraging strong clinical operational and therapeutic expertise (scientific, clinical, disease states, and treatment alternatives knowledge within the therapeutic area(s)) to support execution of the clinical studies.

Responsible for the planning, initiation, coordination and management of all monitoring and monitoring-related activities as well as supervision of all site-related activities to ensure compliance with UCB Standard Operating Procedures (SOPs), Good Clinical Practices (GCP) and regulatory requirements.Engages with clinical sites to develop, build, and maintain strong relationships with investigators/staff that will ensure high quality investigative sites to support UCB's clinical development programs. Collaborate with internal and external stakeholders as well as third party vendors. Provide operational support to the CPM/Sr CPM to deliver the study within planned timelines and according to required standards of quality and compliance. Evaluate, screen and develop high quality investigative sites to support UCB's clinical development programs.

Site Engagement Deliverables:
Develop, communicate, and execute Site Engagement Strategy/Plan working closely with the UCB Clinical Team and key internal stake holders throughout the life cycle of UCB clinical trials
Support UCB clinical team in coordinating and executing site engagement activities by understanding the competitive landscape, capturing trial hurdles and using motivational tactics to ensure timely delivery of UCB trials
Engage, evaluate and develop a global network of high performing sites through coordinated, consistent interactions using multiple communication channels to create awareness of UCB and its activities thereby increasing their desire to partner with UCB
Develop & maintain relationships with site engagement organizations; assist in identification of high performing sites and key opinion leaders that can contribute to UCB forums, boards and/or discussions
Interact/train new investigators to work on UCB clinical trials

Monitoring Deliverables:
Responsible for all kinds of site visits (e.g. Selection / Initiation / Monitoring / Close-out / Motivational / Support) and sites' performance regarding set-up, conduct and data collection
Primary contact for sites regarding study-related issues.
Responsible for the early engagement with Key Opinion Leaders (KOLs)/ sites / patients organizations and key contact point for these throughout the study.
Interact/train new investigators to work on UCB clinical trials.
Attend key therapeutic trainings/meetings and/or industry trainings.
Support CPM in management of the study, including but not limited to:

Vendor management
Training
Logistic
Selection of sites
Maintenance of study tracking
Oversight of eTMF

Close cooperation with the Clinical Project Managers and members of the Clinicial Trial Teams to inform on all aspects of the clincial trial status at site.
Ensure appropriate engagement and communication with internal stakeholders regarding site visits and related activities.
Support the development of key study documents including, but not limited to Case Report Form (CRFs), diaries, informed consent/participant information, the study concept and protocols/amendments including presentations and Investigator Meetings or other trial-related meetings.
Prepare and/or review monitoring tools, e.g. monitoring manual
Support CRO/vendor selection activities and provide input in development of contract specifications regarding monitoring activities for clinical trials.
Review and approval of site regulatory packages
Prepare or review responses to questions from Regulatory Authorities and IRBs/ECs.
Contributes to updates of clincial program information, e.g., annual safety updates, Investigator's Brochure, and on query resolution, as needed, etc.
Depending on trial setting:
Train appropriate internal and CRO personnel on trial-specific monitoring requirements.
Track monitoring activities including review of regulatory package status, visit reports, queries (nature and frequency), and ensure timely collection of the data.
Conduct co-monitoring visits with internal or CRO personnel to ensure quality of trial and initiate corrective actions where appropriate.
Utilising all applicable Decentralised Clinical Trial (DCT) methods.
Shares insights, innovation opportunities and patient needs internally to the team, through collaboration with the UCB innovation/Technology Transformation Implementation (TTI) Teams.
Such other responsibilities and projects that the Company may assign, e.g., cooperation onSOPs.
In collaboration with CPM/study team, ensure that the study is audit/inspection ready at all times and any resulting findings from audits/inspections are addressed appropriately and in a timely manner.

Are you ready to 'go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you

About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.

Why work with us?
At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equitable opportunities to do their best work. We 'go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

As an Equal Opportunity Employer, we are open to all talent, and adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on US-Reasonable_Accommodation@ucb.com for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
#J-18808-Ljbffr

  • Senior Clinical Site Manager

    3 weeks ago

    Raleigh, North Carolina, United States UCB Full time

    Make your mark for patientsMaximizing site performance and site engagement in UCB conducted clinical studies. Leveraging strong clinical operational and therapeutic expertise (scientific, clinical, disease states, and treatment alternatives knowledge within the therapeutic area(s)) to support execution of the clinical studies. Responsible for the planning,...

  • Senior Site Reliability Engineer

    2 weeks ago

    Raleigh, United States Envestnet Asset Management, Inc Full time

    Senior Site Reliability Engineer page is loaded Senior Site Reliability Engineer Apply locations Raleigh time type Full time posted on Posted 30+ Days Ago job requisition id Req 20.357 - It's fun to work in a company where people truly BELIEVE in what they're doing! We're committed to bringing passion and customer focus to the business. Job Description...

  • Site Manager

    1 week ago

    Raleigh, United States SNC-Lavalin Full time

    Lead all on-site activities of a project to assure cost-effective execution of project deliverables in accordance with contract specifications, quality standards, schedule, and safety requirements during the start-up, construction and/or erection, commissioning, maintenance phases of substation. What will you do? 1. Site planning: Plans project on-site...

  • Senior Clinical Research Associate

    2 weeks ago

    Raleigh, United States Optimapharm d.o.o. Full time

    Location: home-basedWho we are?Optimapharm is a leading, mid-sized, full-service CRO working across Europe and North America to deliver new therapies to improve and save patients' lives. Optimapharm's key priorities are our people and consistently exceeding our client's expectations.With 27 strategically located offices, Optimapharm operates in 40+...

  • Site Manager

    1 week ago

    Raleigh, United States Reed Inc Full time

    School Site Manager Job Type: Permanent, Full-time Location: Maidstone Salary: £23,800 to £28,400 per annum We are seeking a dedicated School Site Manager to join the team at a leading primary school in the Maidstone area. The successful candidate will be responsible for maintaining the school premises, ensuring a safe and welcoming environment for...

  • Accountant / CPA - Senior Reporting Analyst

    2 weeks ago

    Raleigh, United States Worldwide Clinical Trials - USA Full time

    Please note: While this is a remote role, candidates must reside in the Raleigh/Durham region Who we are We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches...

  • US - Quality Assurance

    2 weeks ago

    Raleigh, United States Resolute Workforce Solutions Full time

    Job Description Client: Brevitas Corp. Our Global Company, Brevitas Corp., is dedicated to helping organizations achieve tangible results and lasting improvements via successful project delivery, continuous process improvement and effective management of change. We serve businesses in a wide range of industries including Pharmaceuticals, Food & Beverage,...

  • US - Quality Assurance

    4 days ago

    Raleigh, United States Resolute Workforce Solutions Full time

    Job Description Client: Brevitas Corp. Our Global Company, Brevitas Corp., is dedicated to helping organizations achieve tangible results and lasting improvements via successful project delivery, continuous process improvement and effective management of change. We serve businesses in a wide range of industries including Pharmaceuticals, Food & Beverage,...

  • Senior Project Manager

    6 days ago

    Raleigh, United States TFS HealthScience Full time

    Join Our Team as a Senior Project Manager TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions. About this role...

  • Full-time RN Clinical Director

    5 days ago

    Raleigh, United States Always Best Care Senior Services Full time

    Always Best Care Senior Services of South/East Wake and Johnston Counties is looking for a full-time RN Clinical Director. This is an exciting opportunity to help design and build ABC's new Home Health Division from the ground up. This position is a key leadership role that oversees all clinical services in both the non-medical and medical departments of the...

  • Site Project Manager

    4 weeks ago

    Raleigh, North Carolina, United States Siemens Energy Full time

    Site Project Manager About the Role Location United States of America North Carolina Raleigh Company Siemens Energy, Inc. Organization EVP Global Functions Business Unit Project Entity Full / Part time Full-time Experience Level Experienced Professional The Site Manager is responsible for supervising the delivery of an EPC contract involving construction and...

  • Clinical Lead

    2 weeks ago

    Raleigh, United States ProPharma Group Full time

    The Clinical Lead position is responsible for the management of assigned clinical trials with a focus on investigational site management and monitoring activities. The Clinical Lead will ensure that site management and monitoring aspects of clinical trials are executed in accordance with applicable regulations and that the quality of clinical data generated...

  • Clinical Lead

    2 weeks ago

    Raleigh, United States Propharma Group, Inc. Full time

    For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world's largest RCO (Research Consulting Organization), ProPharma partners with...

  • Senior Product Manager

    2 weeks ago

    Raleigh, North Carolina, United States Hitachi Careers Full time

    Description General Information:Hitachi Energy is seeking a Senior Product Manager to lead the product strategy of enterprise software for current and new markets. The position is accountable for the long-term success and cohesion of Hitachi Energy's Lumada asset and work management solutions.The Senior Product Manager is a strategic leadership role that...

  • Principal Clinical Data Manager

    2 weeks ago

    Raleigh, United States Biodata Partners, Inc. Full time

    Job DescriptionJob DescriptionJob Summary:Manage end-to-end delivery of data management services concurrently for single/multi-service projects with little-to-no guidance, ensuring quality deliverables on time and within budget to customer satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high...

  • Senior Project Manager

    4 days ago

    Raleigh, United States Morris & Ritchie Associates Inc Full time

    Established more than 40 years ago, Morris & Ritchie Associates, Inc.'s (MRA's) architects, structural and civil/site engineers, land planners, landscape architects, and surveyors provide planning, design, and construction administration phase services for a wide range of projects throughout the mid-Atlantic and Carolinas. MRA's projects include: office...

  • Senior/Principal Clinical Programmer

    2 weeks ago

    Raleigh, United States Biodata Partners, Inc. Full time

    Job Title: Principal Clinical Programmer Job Code: CDM0016Department Name: Clinical Data Management Reports to Title: Manager or above Job Summary: The Principal Clinical Programmer is a member of the Data Management team and serves as a subject matter expert for Clinical Data Programming, Reporting, Process, and technology. Accountable for the quality and...

  • Full-time RN Clinical Director

    1 week ago

    Raleigh, United States Always Best Care Senior Services - Raleigh, NC Full time

    Job DescriptionJob DescriptionAlways Best Care Senior Services of South/East Wake and Johnston Counties is looking for a full-time RN Clinical Director. This is an exciting opportunity to help design and build ABC's new Home Health Division from the ground up. This position is a key leadership role that oversees all clinical services in both the...

  • Director, Clinical Operations

    2 weeks ago

    Raleigh, United States Verona Pharma PLC Full time

    Director, Clinical Operations", "description": "Director, Clinical Operations The Company: Our mission is to improve the health and quality of life for the millions of people affected by chronic respiratory diseases. We do this through the development of our first-in-class molecule, ensifentrine. Ensifentrine has the potential to provide relief for...

  • Sales Specialist

    2 days ago

    Raleigh, United States Navion Senior Solutions Full time

    Job DescriptionJob DescriptionNavion Senior Solutions is seeking a high-performing Sales Specialist. You will be responsible for providing sales and marketing support to Navion's communities based on need and at the direction of the Vice President of Sales and Marketing. This individual is responsible and accountable for assisting with lead generation,...