Job Description
Clinical Research Manager
Position Location: United States – Remote
Job Code: 3387
# of openings: 1
Clinical Research Manager
US Remote Worker
The Emmes Company, LLC (Emmes) is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.
Our Character Achieves Results culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.
If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee from entry level through top executive to contribute to our clients’ success by sharing ideas openly and honestly.
Primary Purpose
Work together with Casimir’s multidisciplinary team to conduct research using qualitative and quantitative methods. Develop, implement, and coordinate research and administrative procedures for successful management of studies. Perform diverse administrative duties requiring a high level of knowledge of study specific protocols.
Responsibilities
- Administratively and clinically manage all study activities including the coordination of Contract Research Organizations (CROs), vendors and consultants that are involved with the study, and the design and conduct of research studies.
- Coordinate research conduct from study start-up through close-out.
- Protect the rights, safety, and well-being of participants enrolled in studies and ensure the integrity of data with adherence to local and federal regulatory authorities, International Council for Harmonisation (ICH) Good Clinical Practices (GCP), organizational standard operating procedures (SOPs), and study protocols.
- Assist in preparation and ensure compliance of study documentation such as study protocols and informed consent, source documentation, Study Monitoring Plan, Project Management Plan, etc.
- Assist with the development of the operational components of regulatory submissions including, but not limited to safety, interim and final study audits and reports.
- Participate and respond to Quality Assurance, vendor, sponsor and/or regulatory authority inspection audits.
- Contribute to the development of safety, data management, analysis, project management and communication management plans and study design.
- Coordinate and conduct interviews and data collection (e.g. questionnaires, surveys, medical records and audio and video data).
- Complete and manage case report forms (CRFs) and data query resolution via appropriate electronic platforms/systems.
- Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the study, including periodic reviews.
- Establish study milestones and ensure accurate tracking and reporting of study metrics, timelines, and deliverables.
- Participate in program strategy meetings, ad hoc clinical operations initiatives and programs.
- Lead and manage internal and external study meetings and trainings, as applicable.
Experience
- A Bachelor’s degree in science or related field is required.
- A minimum of three (3) years of experience as integral team support for clinical trials for or within the biotech or pharmaceutical industry, including CRO/vendor management, monitoring of budget scope, clinical site monitoring, protocol, informed consent form (ICF), CRF, clinical study report (CSR) development and review and knowledge of basic data management
- Knowledge of global clinical trial management in fast paced CRO outsourced environment, including interpretation and implementation of Food and Drug Administration (FDA) regulations/ICH guidelines is required
- Prior experience with early phase, qualitative research methods, and dose escalation/Proof of Concept study management is preferred
- Excellent oral and written communications
- Ability to work remotely, flexibly, and independently while meeting project deadlines
- Ability to establish study operational plans and strategy that requires a balance of scientific and operational/project management and team leadership expertise
- Strong technological skills, including knowledge of Microsoft Suite, storage applications, and online audio and video conferencing systems
- Excellent organizational and priority management skills with ability to work with established timelines in a fast-paced environment
- Strong interpersonal skills and ability to manage teams at all levels with sensitivity and tact
Emmes is a federal government contractor and requires all employees to be fully vaccinated against COVID-19, to the extent permitted by applicable law. Individuals with medical conditions or sincerely religious beliefs or practices that prevent them from getting the vaccine may request an exemption from the vaccine requirement.
Why work at Emmes?
At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program.
The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.
