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.
Reporting to the Senior Director, Clinical Operations, the Senior Manager, Clinical Operations ensures oversight of clinical operations activities including developing goals/milestones for clinical study programs, identifying and evaluating clinical sites and CROs, site management and monitoring activities, and GCP compliance training. The Senior Manager leads the clinical trial delivery team and providing overall direction, training, coaching and mentoring to the clinical operations team to support departmental and organizational objectives.
Develop staff and creating a desirable work environment in order to attract and retain qualified clinical operations professionals
Ensure department compliance with regulations, guidelines, GCP and procedures
Serve as an escalation point or support oversight of highly complex clinical studies with a team of supporting clinical operations team members.
Acountable for oversight of financial and human resource management including work assignments, forecasting, planning and tracking.
Oversees management of Request for Proposals (RFPs), evaluation and selection for outsourced studies.
Oversees the development, negotiation and implementation of site/vendor contract budgets to align with internal approved project budgets
Collaborate with clinical program management to enable ongoing forecasting and accruals to internal stakeholders.
Develops, prioritizes and meets measurable short- and long-term goals for clinical study programs.
Oversees the management and direct service providers including CRO(s) for conducting global clinical drug development programs that support regulatory approval and subsequent commercialization.
Monitors the progress of clinical study programs, in conjunction with the Clinical Program Manager, and addresses problems as necessary.
Provides input into design and implementation of clinical protocols with appropriate functional area stakeholders.
Establishes expectations for clinical operations to interact with internal stakeholders, e.g. appropriate communication plans/study plans
Collaborate with clinical QA to ensure consistent auditing, corrective action and maintenance of GCP compliance for clinical studies
Review, maintain, and develop Clinical Operations SOP’s;
Model core values and support organizational objectives
Travel may be required for this position both domestically and internationally
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.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
Candidates must have at minimum, a bachelor’s degree, preferably in Life Sciences, accompanied by 5-7 years’ experience or an equivalent combination of education and experience. Must have or an equivalent Experience in the pharmaceutical or Biotech industry and/or a master’s degree or PhD would be an asset.
Direct experience in managing successful teams is required communicate goals, motivate team members, overcome obstacles.
Demonstrate competence in building high performing teams.
Must have extensive knowledge and understanding of ICH and regulatory requirements and procedures applicable to Clinical Research.
Must have the ability to set and achieve results within budget and timeline specifications.
Excellent organizational, analytical, leadership, problem solving, written/verbal communication, computer and interpersonal skills required.
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.