table style="margin:0px;padding:0px;border-collapse:collapse;width:auto;color:#000000;font-family:'roboto' , 'helvetica neue' , 'helvetica' , 'arial' , sans-serif;font-size:12px;font-weight:400;border:none">- Flexible Approved Time Off.
Ensures study timelines and deliverables are met by CRA staff, including, but not limited to, development of the clinical monitoring plan per the Statement of Work (SOW), evaluation of the risk-based monitoring strategy, monitoring visit frequency, monitoring visit report submission/approval timelines, study data collection timelines, and the annotated reports per the project SOW and/or Emmes SOPs. Partnering with the University of Maryland School of Medicine, University of Maryland School of Nursing and University of Maryland, Baltimore who educate the state's future health care professionals, UMMS is an integrated network of care, delivering 25 percent of all hospital care in urban, suburban and rural communities across the state of Maryland. UMMS puts academic medicine within reach through primary and specialty care delivered at 11 hospitals, including the flagship University of Maryland Medical Center, the System's anchor institution in downtown Baltimore, as well as through a network of University of Maryland Urgent Care centers and more than 150 other locations in 13 counties. Rockville, MD30+ days ago The successful candidate will lead/co lead clinical research activities in support of three key initiatives: - Clinical research supporting activities within the Clinical Development Group (phase I - III trials) and regulatory filing of pipeline products.
Leads or Co-leads (with commercial colleagues) effort in determining and articulating the attributes related to safety, efficacy, unmet medical need, regulatory approval and successful commercialization of ongoing development and pipeline candidates.
Owings Mills, Maryland30+ days ago ul style="margin-top:0in;margin-bottom:0.0001pt">- Communicates, cooperates, and consistently functions professionally and harmoniously with all levels of supervision, co-workers, patients, visitors, and vendors. When you join RadNet as Revenue Cycle Operations – Project Manager, you will be joining a dedicated team of professionals who deliver quality, value, and access in the 21st century and align all stakeholders- patients, providers, payors, and regulators achieve the best clinical outcomes.
li>Possesses basic knowledge of the study protocol, site monitoring plan, and study manuals to triage questions or requests from site staff e.g., enrollment updates, questions, missing documentation, meeting arrangements, etc. With over 47 years of scientific excellence, we’ve led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience.. li>Possesses basic knowledge of the study protocol, site monitoring plan, and study manuals to triage questions or requests from site staff e.g., enrollment updates, questions, missing documentation, meeting arrangements, etc. With over 47 years of scientific excellence, we’ve led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience.. Rockville, MD30+ days ago Reporting directly to the Vice President of Operations, Client Delivery Services, the Project Director collaborates with Practice Area Leads, Technical Operations leadership, and cross-functional teams to ensure excellence in execution, financial performance, and client satisfaction while driving innovation across the health-research ecosystem. This role provides scientific, operational, and programmatic leadership for a multidisciplinary team delivering comprehensive project management, regulatory oversight, data and safety monitoring coordination, analytics, and recruitment support for Alzheimer’s disease and aging-related studies. Rockville, MD30+ days ago li>Bachelors-degree-in-medical-lab-science-or-equivalent,-or-health-care-related-field-AND-minimum-six-(6)-years-of-experience-in-medical-technology,-clinical-laboratory-sciences,-or-health-care-related-field-OR-Minimum-nine-(9)-years-of-experience-in-medical-technology,-clinical-laboratory-sciences,-or-health-care-related-field. - Bachelors degree in medical lab science or equivalent, or health care related field AND minimum six (6) years of experience in medical technology, clinical laboratory sciences, or health care related field OR Minimum nine (9) years of experience in medical technology, clinical laboratory sciences, or health care related field.
ul>- Master's degree in a scientific, engineering, or biotechnology field with 6+ years' experience in GMP manufacturing operations within biologics/biopharmaceuticals (plasmids, vaccines, microbial fermentation, or related) OR Bachelor's degree in a scientific, engineering, or biotechnology field with 8-10+ years' experience in GMP manufacturing operations within biologics/biopharmaceuticals (plasmids, vaccines, microbial fermentation, or related). Our FDA-licensed, state-of-the-art CGMP gene therapy campus in Harmans, MD-just minutes from BWI Airport-features EMA and FDA-approved manufacturing suites, fill/finish capabilities, labs, and warehousing to support Phase 3 through commercial production of advanced therapies, including AAV and other viral vector-based products.
Harmans, Maryland16 days ago ul>- Master’s degree in a scientific, engineering, or biotechnology field with 6+ years’ experience in GMP manufacturing operations within biologics/biopharmaceuticals (plasmids, vaccines, microbial fermentation, or related) OR Bachelor’s degree in a scientific, engineering, or biotechnology field with 8–10+ years’ experience in GMP manufacturing operations within biologics/biopharmaceuticals (plasmids, vaccines, microbial fermentation, or related). Our FDA-licensed, state-of-the-art CGMP gene therapy campus in Harmans, MD—just minutes from BWI Airport—features EMA and FDA-approved manufacturing suites, fill/finish capabilities, labs, and warehousing to support Phase 3 through commercial production of advanced therapies, including AAV and other viral vector-based products.
Harmans, Maryland15 days ago div>The Manager, Commercial Operations is responsible for leading the transition of client programs following contract execution, serving as the primary business contact for assigned portfolios and driving cross-functional alignment to ensure efficient delivery and a seamless client experience. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. p>The Manager, Commercial Operations is responsible for leading the transition of client programs following contract execution, serving as the primary business contact for assigned portfolios and driving cross-functional alignment to ensure efficient delivery and a seamless client experience. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. Baltimore, MD30+ days ago We are seeking a team-oriented Clinical Research Physician who thrives in a fast-paced, highly specialized research environment and is passionate about mentoring and supporting clinical staff. This role offers the opportunity to contribute to clinical research, collaborate with cross-functional teams and engage directly with sponsors and partners. Owings Mills, MD30+ days ago p>Strive towards mastery of role by prioritizing and completing all PMO Training needed to develop technical, commitment and leadership skills • Develop and pursue annual top 10 business goals and 16 personal development goals (5 technical, 5 commitment, 6 personality) • Ensure goals and priorities of Doctors and teams are achieved through servant leadership • Bell Leadership Training every 18-24 months • Support the Doctor Led, Hygiene Driven, Operations focus philosophy through synergy meetings monthly, team meetings weekly, and strong morning huddles • Focus and prioritize efforts of team to support Doctor achieving their Top 10 Professional goals • Create alignment with doctor through daily one on ones, morning huddles and weekly touch points discussing communication, connection and support needed • Commit to serving as a business partner for the Doctor collaborating and developing quarterly and annual financial goals • Help Doctor prioritize, plan and block schedule for CE through Doctor Education and Leadership programs • Understand the benefits and metrics of DMP and help Doctor to monitor progress • Identify and support future team growth by selecting candidates (BA, DA, Hygienists) that are an 80% match for both the position and the practice • Partner with Doctors to identify skills needed for open positions and proper selection team within the practice • Successfully onboard new team members through partnerships with recruiting and support office • Support team members to prioritize and plan their training through Core Essentials and beyond for growth in their roles. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties of the position • Prolonged periods sitting at a desk and working on a computer • Must be able to lift up to 15 pounds at times • Availability to attend virtual training sessions (or in-person once conditions allow) periodically throughout the year (some travel will eventually be involved) • As part of our commitment to maintaining a safe and healthy environment for both team members and patients, a tuberculosis (TB) test is required for all new hires in dental office positions. The Senior Manager of Front-End RCM Operations leads the end-to-end patient access, financial clearance, coding, and charge entry functions with primary focus areas including insurance verification, medical necessity review, prior authorizations, patient financial communication, coding accuracy, and charge capture. Bachelor’s degree in healthcare administration, business, or a related field of study WITH five (5) years of experience in Revenue Cycle Management with direct oversight of pre-certification, authorization, coding, or charge entry teams; OR an equivalent combination of education and/or experience. Rockville, MD30+ days ago p>Serves as a link between medical laboratory services and other services by: • Planning for the alignment of current practices with regulatory/accreditation changes and issues, inspection citations, current events, and trends relevant to services, quality, and training. Manages designated work unit or team by translating business plans into tactical action items; oversees the completion of work assignments and identifies opportunities for improvement; ensures all policies and procedures are followed. p>Serves as a link between medical laboratory services and other services by: • Planning for the alignment of current practices with regulatory/accreditation changes and issues, inspection citations, current events, and trends relevant to services, quality, and training. Manages designated work unit or team by translating business plans into tactical action items; oversees the completion of work assignments and identifies opportunities for improvement; ensures all policies and procedures are followed. Rockville, MD30+ days ago Serves as a link between medical laboratory services and other services by: • Planning for the alignment of current practices with regulatory/accreditation changes and issues, inspection citations, current events, and trends relevant to services, quality, and training. • Manages designated work unit or team by translating business plans into tactical action items; oversees the completion of work assignments and identifies opportunities for improvement; ensures all policies and procedures are followed. Gaithersburg, MD30+ days ago 136,500 - $227,500 About the CompanyImmunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Vacancy NameAssociate Director, Global Pharmacovigilance / Safety Operations Vacancy NoVN801 Employment TypeFull Time Location of roleGaithersburg, MD, Radnor, PA, Oxford, UK DepartmentRegulatory Affairs Key ResponsibilitiesThe Associate Director, Safety Operations is a key operational leader responsible for the execution and management of global pharmacovigilance operations. Monitor and review study budget and data management activities, such as PRF development, training, and facilitating query resolution with proper documentation • Support monitoring efforts by setting quality and compliance goals by overseeing and approving study monitoring plans, may review, suggest edits and approve monitoring trip reports • Contribute to contract review and negotiations with outside vendors and study sites or laboratories • Mentor CTMs and CRAs • Demonstrate an ability to influence others to achieve positive results and collaboration through diplomacy and respect for others, appropriate prioritization and facilitation of the decision-making process Qualifications Qualifications: • Bachelors degree or higher, or equivalent credentials • Knowledge of GCP, ICH guidelines, and other clinical regulatory requirements • Strong interpersonal skills (verbal and written), organizational, and prioritization skills, able to communicate at multiple levels of an organization and with sponsors/clients. Primary Responsibilities (all levels): • Manage, design and implement all clinical operational aspects of IVD clinical trials from inception through close-out • Serve as main point of contact for internal and external study stakeholders; effectively communicating, collaborating, managing escalation of issues, where necessary, as well as participating and leading internal and external study meetings • Identify, evaluate, and oversee qualification and contracting for study investigators, study sites, CRO and/or vendor management for the study, where applicable • Develop or assist in the development of study-related plans and documents including protocols, informed consent forms, monitoring plans, case report forms, training plans and engagement materials • Ensure trial master file (TMF/eTMF) is established, current, and maintained per ICH E6. Keywords: Clinical Research, Clinical Trials, Clinical Operations, In-House CRA, TMF, Trial Master File, eTMF, Veeva Vault, Regulatory Documents, Regulatory Affairs, Document Management, ICH GCP, FDA Regulations, Good Clinical Practice, Essential Documents, Site Document Collection, IRB Submissions, OHRP Regulations, Site Start-Up, Study Coordination, Clinical Study Support, Monitoring Support, TMF Maintenance, Document Tracking, Compliance, Audit Readiness, Clinical Data Management, Sponsor Oversight, CRO, Protocol Compliance, Investigator Communication, Site Management, Clinical Systems, Database Tracking, Microsoft Excel, Microsoft Word, Microsoft Outlook. Responsibilities of the In-House Clinical Research Associate include: Review and process essential regulatory documents received from clinical trial sites. Bethesda, Maryland9 days ago Reporting to the Senior Manager of Regulatory Affairs & Data, this role directly oversees a small, dedicated team (including a Clinical Data Manager and a Data Management Analyst) supporting a robust portfolio of 65+ active multi-site research studies, including federally funded, FDA-regulated and industry-sponsored clinical trials, across military treatment facilities, academic institutions, and other sites nationwide. Headquartered at the Uniformed Services University of the Health Sciences (USU) in Bethesda, MD, MIRROR provides coordination and support of inter-service and inter-disciplinary partnerships across military treatment facilities (MTFs), military training centers (MTCs), and civilian academic centers to execute cutting-edge research in order to mitigate the burden of MSI on military readiness. p>The Senior Manager of Front-End RCM Operations leads the end-to-end patient access, financial clearance, coding, and charge entry functions with primary focus areas including insurance verification, medical necessity review, prior authorizations, patient financial communication, coding accuracy, and charge capture. Minimum Qualifications: - Bachelors degree in healthcare administration, business, or a related field of study WITH five (5) years of experience in Revenue Cycle Management with direct oversight of pre-certification, authorization, coding, or charge entry teams; OR an equivalent combination of education and/or experience.
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