Specialist, Clinical Trials

Gaithersburg, MD, US
Nov 05, 2020
Required Education
Bachelors Degree
Position Type
Full time
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.

The Specialist, Clinical Trails (Clinical Trials Manager CTM) is responsible for independently managing clinical studies deliverables according to Emergent Standard Operating Procedures, ICH GCP and regulatory guidelines. This role interacts significantly with internal and external functional groups to maintain and develop systems which promote regulatory compliance, enhance efficiency, and achieve organizational goals.
The position is accountable for ensuring clinical trial activities and deliverables are completed on-time, within budget and quality standards in a highly dynamic and complex environment.

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
  • Collaborate with the Clinical Program Manager to create and maintain study timelines, risk registry, operational logistics and assess study progress to ensure all stakeholders are informed and aligned on trial deliverables.
  • Support and collaborate with the internal and external stakeholders to achieve departmental goals and the implementation of mitigation strategies to ensure timelines are met.
  • Responsible for the preparation and ongoing review of study documents throughout the lifecycle of the clinical trial.
  • Responsible for vendor management; including RFP review process, contracts/budget, performance accountability, invoice review and timeline management.
  • Lead Study Team Meetings including Study Kick-off Meeting, and attend Core Team meetings, as needed.
  • Provide required data from studies and sites to comply with regulatory and government requirements (Sunshine Act, FWA, Human Subject Protection training, Clinical Insurance).
  • For government funded studies, collaborates with government agency, contracts group and external vendors to adhere to agency requirements.
  • Manage and oversee the coordination of study activities.
  • 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.
  • Responsible for data integrity and accuracy throughout the Clinical Trial lifecycle.
  • Assure appropriate oversight for sample management (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.
  • Acts as clinical representative at regulatory inspections.
  • Model Emergent core values and support overall organizational objectives.

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.

• The completion of a bachelor's degree in life sciences, accompanied by over five years' relevant experience, or an equivalent combination of education and experience.
• 2 years of clinical trial monitoring experience preferred.
• Thorough knowledge of ICH Guidelines and GCP including an understanding of regulatory requirements.
• 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.
• 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

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.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

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.

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