Clinical Lead

3 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 from clinical trials
meets the requirements for Regulatory Authority approval. This position
provides strategic and tactical operational planning and execution of site
management and monitoring activities for assigned trials.

Essential Functions:

  • Oversight and management of the investigator site management and monitoring activities and the clinical monitoring teams for the assigned studies during the startup, execution, and close out phase of the study.
  • Functions as the lead site management resource for the client, investigational site, and the internal study team.
  • Ensures all monitoring activities for assigned projects are conducted according to study plans, relevant processes, and standard operating procedures (SOPs), GCP/ICH guidelines and other applicable regulations.
  • Provides input and supports development of study specific training material, and as appropriate provides study-specific training for the assigned clinical monitoring teams.
  • Oversees quality of clinical monitoring deliverables to clients and may conduct Quality Co-monitoring visits to ensure data quality and monitoring performance metrics are being met and develop solutions to optimize performance.
  • Responsible for the review and approval of study monitors’ site visit reports for the investigational sites on assigned studies within appropriate process requirements.
  • Works closely with clinical project manager and contributes to development of the clinical study specific plans as assigned. This includes but is not limited to clinical monitoring plan. Also responsible for creating and updating study specific tools and templates related to clinical site management and monitoring.
  • Assures compliance with study monitoring plan and collaborates with cross functional teams to ensure timely site initiate process.
  • Leads and supports any study specific requirements related to site performance, including but not limited to patient recruitment, site payments, study material needs, etc.
  • Works closely with clinical project management team and provides status report for onsite initiations, enrollment, visit schedules, trip report completion and any other status report as per the company and/or project specific requirements.
  • Works closely with the clinical project management team and the cross functional teams while keeping them apprised of any issues and seeking guidance as needed.
  • Maintains timely and effective communication among team members and site personnel as assigned.
  • May be responsible for the supervision and administrative oversight of the direct reports within the company expected framework. The direct report personnel may be clinical research associates (CRAs) or any other clinical team members if deemed appropriate.
  • Other duties as assigned

Necessary Skills and Abilities:

  • Demonstrated ability to perform CRA activities at an advanced level.
  • Demonstrated ability to lead a team of Clinical Operations professionals in the successful execution of clinical trials.
  • Demonstrated ability to develop and maintain effective relationships with study site personnel and a track record of positively influencing them to achieve study goals.
  • Experience managing/mentoring and developing junior staff.
  • Experience using Microsoft Office (Word, Excel, Power Point) applications to prepare charts, tables, forms, reports, and presentations.
  • Experience in working in eTMF, CTMS, EDC, DCT and overall systems that support conduct of clinical trials.
  • Extensive understanding of SOPs, Works Instructions, regional regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
  • Excellent verbal and written communication skills; interpersonal and presentation skills are required.

  • Clinical Lead

    3 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...

  • Vice President, Global Site Management

    12 hours ago

    Raleigh, United States Worldwide Clinical Trials - USA Full time

    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 and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a...

  • Lead Enrollment Associate

    5 days ago

    Raleigh, United States CVS Pharmacy Full time

    The Lead Enrollment Associate is responsible for establishing an expertise in all Clinical programs and Enrollment processes to help provide guidance, mentoring, and back up for the Enrollment Assistants. Lead Enrollment Associates will also assist t Enrollment, Associate, Leadership, Lead, Skills, Retail, Business Services

  • Clinical Director

    3 days ago

    Raleigh, United States Mosaic Pediatric Therapy Full time

    Job DescriptionJob DescriptionClinical DirectorAbout UsMosaic Pediatric Therapy is a leading provider of life-changing therapy for children with autism and learning disabilities across North Carolina, Virginia, and Tennessee. We are confident our unwavering focus on integrating our core values into every aspect of our decision-making will continue to drive...

  • Business Analyst

    3 weeks ago

    Raleigh, United States Worldwide Clinical Trials - USA Full time

    Who we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on...

  • Clinical Solution Analyst

    3 weeks ago

    Raleigh, United States Integrated Resources, Inc Full time

    Please note: in line with *** policy, this role is VDI only. *** will not be providing a laptop or equipment. Primary Purpose / Regulatory Responsibilities: A primary function of this position is to globally provide skilled Key User oversight of clinical applications and data repositories, including system upgrades and change requests to be implemented...

  • Clinical Secretary, eICU

    5 days ago

    Raleigh, United States WakeMed Full time

    About WakeMed:Serving the community since 1961, WakeMed Health & Hospitals is the leading provider of health services in Wake County. With a mission to improve the health and well-being of our community, we are committed to providing outstanding and compassionate care. For more information, visit www.wakemed.org.EOEPosition Information:The Clinical Secretary...

  • Clinical Secretary, eICU

    6 days ago

    Raleigh, United States WakeMed Full time

    About WakeMed:Serving the community since 1961, WakeMed Health & Hospitals is the leading provider of health services in Wake County. With a mission to improve the health and well-being of our community, we are committed to providing outstanding and compassionate care. For more information, visit www.wakemed.org.EOEPosition Information:The Clinical Secretary...

  • Clinical Nurse Specialist

    1 month ago

    Raleigh, United States WakeMed Full time

    Job DescriptionAbout WakeMed:Serving the community since 1961, WakeMed Health & Hospitals is the leading provider of health services in Wake County. With a mission to improve the health and well-being of our community, we are committed to providing outstanding and compassionate care. For more information, visit www.wakemed.org.EOEPosition Information:The...

  • Clinical Secretary, eICU

    2 days ago

    Raleigh, United States WakeMed Full time

    About WakeMed: Serving the community since 1961, WakeMed Health & Hospitals is the leading provider of health services in Wake County. With a mission to improve the health and well-being of our community, we are committed to providing outstanding and compassionate care. For more information, visit www.wakemed.org. EOE Position Information: The Clinical...

  • Lead Ophthalmic Technician/Medical Scribe

    7 days ago

    Raleigh, United States North Carolina Retina Associates Full time

    Lead Ophthalmic Technician/Medical Scribe.Now hiring highly motivated, organized individuals to work as clinical technicians for the largest Retina Practice in North Carolina. We are hiring to staff all of our clinics including:Raleigh, North Raleigh, Cary, Fuquay Varina, Clayton, Greenville, Chapel Hill, and Wake Forest.We are looking to hire experienced...

  • Asset Quality Lead

    1 week ago

    Raleigh, United States UCB S.A. Full time

    Make your mark for patientsWe are looking for an Asset Quality Lead who is cooperative, insightful and quality-minded to join us in our Quality Assurance team, based in either our Raleigh, NC or Braine, Belgium office locations.About the roleAs part of the Global Quality Assurance Organization, the Asset Quality Lead (AQL) is responsible to create value, by...

  • Asset Quality Lead

    2 weeks ago

    Raleigh, United States UCB Full time

    Make your mark for patients We are looking for an Asset Quality Lead who is cooperative, insightful and quality-minded to join us in our Quality Assurance team, based in either our Raleigh, NC or Braine, Belgium office locations. About the role As part of the Global Quality Assurance Organization, the Asset Quality Lead (AQL) is responsible to create value,...

  • Asset Quality Lead

    2 weeks ago

    Raleigh, United States UCB S.A. Full time

    Make your mark for patients We are looking for an Asset Quality Lead who is cooperative, insightful and quality-minded to join us in our Quality Assurance team, based in either our Raleigh, NC or Braine, Belgium office locations. About the role As part of the Global Quality Assurance Organization, the Asset Quality Lead (AQL) is responsible to create value,...

  • Clinical Secretary, eICU

    5 days ago

    Raleigh, United States WakeMed Full time

    Job DescriptionAbout WakeMed:Serving the community since 1961, WakeMed Health & Hospitals is the leading provider of health services in Wake County. With a mission to improve the health and well-being of our community, we are committed to providing outstanding and compassionate care. For more information, visit EOEPosition Information:The Clinical Secretary...

  • Clinical Aide

    1 month ago

    Raleigh, North Carolina, United States WakeMed Health & Hospitals Full time

    About WakeMed: Serving the community since 1961, WakeMed Health & Hospitals is the leading provider of health services in Wake County. With a mission to improve the health and well-being of our community, we are committed to providing outstanding and compassionate care. For more information, visit EOE Position Information: The Clinical Aide provides...

  • Clinical Secretary, eICU

    6 days ago

    Raleigh, United States WakeMed Full time

    Job DescriptionAbout WakeMed:Serving the community since 1961, WakeMed Health & Hospitals is the leading provider of health services in Wake County. With a mission to improve the health and well-being of our community, we are committed to providing outstanding and compassionate care. For more information, visit www.wakemed.org.EOEPosition Information:The...

  • Clinical Coordinator RN

    2 days ago

    Raleigh, United States WakeMed Full time

    Job DescriptionAbout WakeMed:Nursing Benefits/Highlights:• Sign-On Bonus and/or Relocation Incentive available for select positions• Competitive Benefits Package• Tuition Reimbursement• Public Service Loan Forgiveness• Free Onsite Parking• Professional Development OpportunitiesServing the community since 1961, WakeMed Health & Hospitals is the...

  • Technical Lead

    2 weeks ago

    Raleigh, United States Katalyst Healthcares and Life Sciences Full time

    Responsibilities: looking for a pure validation resource with periodic review, audit experience. We are 10 + years Experience in Validating GxP applications. Experience in FDA and/or Global regulated environment with good understanding of GCP , GLP and Risk based validation strategy. Provides consultation and counseling on Risk and Compliance module...

  • Clinical Coordinator RN

    3 days ago

    Raleigh, United States WakeMed Full time

    About WakeMed:Nursing Benefits/Highlights:• Sign-On Bonus and/or Relocation Incentive available for select positions• Competitive Benefits Package• Tuition Reimbursement• Public Service Loan Forgiveness• Free Onsite Parking• Professional Development OpportunitiesServing the community since 1961, WakeMed Health & Hospitals is the leading provider...