Specialist, Clinical Trials (Remote)
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
I. JOB SUMMARY
The Specialist, Clinical Trials (Clinical Trials Manager CTM) is responsible for independently managing complex clinical trial delivery according to Emergent Standard Operating Procedures, ICH GCP and regulatory guidelines. This role interacts primarily with Clinical Research, Pharmacovigilance, Data Management and Biostats, but also liaises with other functional groups to maintain and develop systems which promote regulatory compliance, enhance efficiency, and achieve organizational goals.
The Clinical Trial Manager is accountable for ensuring clinical trial activities and deliverables are completed on-time, within budget, and in a highly dynamic and complex environment.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Facilitate/Chair study Study team meetings including Study Kick-off meeting, and may attend Core Team meetings
• Provide required data from studies and sites to comply with regulatory and government requirements (Sunshine Act, FWA, Human Subject Protection training, Clinical Insurance).
• Participate and oversee the preparation and ongoing review of study documents
• Support and collaborate with the Clinical Trial team in achieving its departmental goals
• Responsible for Vendor management; including RFP review process, contracts/budget, performance accountability, invoice review and timeline management
• Responsible for input into study timelines, risk registry, operational logistics and assess study progress against QTL's, KPI's and generate trend reports
• Responsible for oversight of setup and maintain Clinical systems and tracking tools (CTMS. eTMF, RTSM, etc)
• Oversee ongoing document review and collection into the TMF throughout study start-up, maintenance and close-out periods. Collaborate with Regulatory, Quality and other departments as necessary to ensure appropriate oversight of TMF.
• Manage and oversee the coordination of study start-up activities (site feasibility, site selection, essential document collection/review, budget/contract negotiations, site activation, clinical trial registration, trial insurance, etc.)
• Oversee Investigational Product Management (labelling, packaging, shipping, temperature excursions, accountability/reconciliation, destruction)
• Manage and oversee monitoring or co-monitoring visits and trip report review according to Clinical Monitoring plan
• Ensure and oversee tracking of subject status throughout the study at investigative sites through collaboration with data management by monitoring subjects’ safety trends and alerts, and protocol deviations (track, report, follow-up)
• Responsible for data integrity and accuracy throughout the Clinical Trial lifecycle.
• Assure appropriate oversight for collection and tracking clinical samples from clinical sites to central labs and vendors
• Assist in managing the study budget, forecast, reconciliations and task order changes
• Conduct and coordinate meetings between Emergent and Vendors, Contract CRAs, Investigative Sites, as needed
• Assist with external data reviews and database lock activities
• Manage and oversee the coordination of site close-out activities (monitoring, reconcile/archive TMF, reconcile & dispose of IP and biological samples, vendor financials, update clinicaltrials.gov, etc.)
• Participate in interim and final study report preparation for regulatory submissions
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
• BA/BS degree or higher, preferably in life sciences with 5 years of relevant experience
• 2 years of monitoring experience preferred.
• Thorough knowledge of ICH Guidelines and GCP including an understanding of regulatory requirements,
• Able to evaluate work performed against Scope of Work (SOW) documentation and lead portion of study tasks.
• Excellent oral and written communication skills required with the ability to effectively understand and present information and deal confidently with internal and external stakeholders.
• Initiative, excellent attention to detail, with highly-developed organizational, and time-management skills are required.
• Anticipates and proactively identifies, recommend creative solutions or escalate issues for project resolution.
• Computer literate with well-developed skills in the use of Microsoft suite of programs (Word, Excel, PowerPoint, Visio, and Outlook).
• Prior experience with eTMF, CTMS and EDC systems preferred
• Travel may include up to 30% predominantly in the United States and/or Canada but may include international travel. Travel may exceed 30% based upon business needs.
IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
Successful applicants for this position that are required to be onsite at any Emergent site at any time, must be fully vaccinated against COVID-19 as a condition of employment, subject to legally required exemptions.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.