1+ months

Sr Manager, Clinical Trials (Remote)

Oxnard, CA 93033 Work Remotely
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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 Senior Clinical Trials Manager (Sr. CTM) is accountable for oversight and execution of multiple, concurrent, 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. As identified by business/program needs, the Sr. CTM may be assigned to supervise direct reports.

II. ESSENTIAL FUNCTIONS
Collaborate with the Clinical Program Manager 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 oversight of the generation and ongoing review of study plans and documents throughout the lifecycle of the clinical trial.
Accountable for Vendor management, including RFP review process, contracts/budget, performance accountability, invoice review and timeline management.
Achieve internal and external milestones and deliverables through communication and influence.
Lead Clinical Study Team Meetings including Study Kick-off Meetings and ongoing study oversight 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 (IP) Management (forecasting IP needs; support role for labelling packaging, shipping, temperature excursions; responsible for accountability,reconciliation, verification of disposition.
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
Collaborates with QA to ensure appropriate auditing of service providers and clinical study sites during study conduct.
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.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

The completion of a bachelors degree in life sciences, accompanied by 7+ years relevant experience, or an equivalent combination of education and experience.
Clinical trial monitoring experience preferred.
At least 5+ years of clinical study management experience.
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.

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.

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.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actionswhether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the communitywe strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.

Industry

  • Biotechnology
Posted: 2022-05-23 Expires: 2022-10-01

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Sr Manager, Clinical Trials (Remote)

Emergent BioSolutions Inc.
Oxnard, CA 93033
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