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 Sr Specialist, Clinical Trails (Sr Clinical Trials Manager Sr. CTM) is accountable for executing multiple concurrent, complex clinical trials on-time and within budget in a highly dynamic and complex global environment. 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 Sr. CTM may also be assigned to supervise direct reports as identified by business/program needs. The position plays a key role in supporting the Clinical operation team in achieving its organizational goals.
- Collaborate with the Program Management team to create and maintain study timelines, risk registry and 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, manage internal and external expectations and deliverables through communication and influence.
- Lead Study Team Meetings including Study Kick-off Meetings, and may participate in Core Team meetings
- Ensure all 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 start-up, conduct and close-out activities
- Contribute to strategic activities related to regulatory intelligence and change management.
- Oversee Investigational Product Management (labelling, packaging, shipping, temperature excursions, accountability/reconciliation, destruction)
- Manage and oversee monitoring and co-monitoring visits and trip report reviews according to the 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 collection and tracking clinical samples from clinical sites to central labs and vendors
- Submit recommendations for study budget, forecast, reconciliations and task order changes
- Acts as clinical representative at regulatory inspections
- Model emergent core values and support overall organizational objectives. Support junior clinical trial team members in their career development, either directly or indirectly.
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
Education, Experience & Skills
- The completion of a bachelor's degree in life sciences, accompanied by over seven years' relevant experience, or an equivalent combination of education and experience.
- Over five years of clinical trial monitoring experience preferred.
- Experience overseeing Clinical Research Associates preferred.
- Knowledgeable in Global requirements for study implementation.
- Has the ability to deal with multiple competing timelines and assignments, prioritizing successfully.
- Ability to influence without authority with internal and external stakeholders.
- 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.
- Advanced computer 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 be required, predominantly in the United States and/or Canada but may include international travel.
PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
- 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 does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by 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.