Clinical Systems Manager -Remote

Location
Gaithersburg, MD, US
Posted
Apr 21, 2021
Ref
735338300
Hotbed
BioCapital
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.

Direct and oversee integration of eClinical technologies into the Emergent Clinical Development environment. Responsible for the development and governance of the overall global framework for the Clinical Development Group's electronic study management system (eClinical System), ensuring ongoing compliance with current Good Clinical Practices (GCPs), regulatory requirements, department SOPs and company policies.
The Global eClinical Systems Lead interacts primarily with the Clinical Development functional areas, IT, Clinical Quality Assurance, and Quality Validation, as required to maintain regulatory compliance, achieve organizational objectives and promote operational excellence. This role is a remote role that can be located anywhere in the US.

Essential Functions

Strategy/Needs

• In collaboration with Clinical Leadership, develop and establish innovative strategic direction of eClinical functionality to align with business demands and industry best practices.

• Lead development and presentation of business cases to support authorization for enterprise level changes within the eClinical functionality.

• Coordinate effective integration of eClinical functionality through interactions with relevant functional groups, IT, IT validation and Quality.
• Manage strategic partnership with eClinical system vendor, facilitating consistency of interactions across projects and clinical study teams.
• Collaborate with functional area managers to define system needs and associated performance requirements
o Lead project teams associated with expansion of eClinical system functionalities
o Liaise with Clinical Quality Assurance to support the change management process
• Serve as the internal expert on the functionality and processes pertaining to the CTMS and eTMF within the eClinical system. Serve as the technical lead point of contact for these modules during implementation of new functionality.
• Coordinate User Acceptance Testing (UAT) execution across eClinical system
• Collaborate with the Director of Clinical Data Management Systems on the building and testing of RTSM modules
Quality / Standards / SOPs
• Liaise with appropriate SMEs to lead development of global SOPs, workflows and policies associated with the eClinical system ensuring compliance with existing regulatory requirements, and GCP guidelines.
• Liaise with Clinical Quality Assurance to ensure quality reviews of the eClinical system performance are conducted accordingly.

• Lead, establish and maintain global standards and governance within the eClinical system

• Evaluate and implement process improvements aimed at enhancing quality and efficiency within Clinical Operations and the eClinical system

• Establish guidance documents and training curricula for Clinical personnel for processes and workflows associated with the eClinical system in collaboration with internal functions and with the eClinical vendor

• Establish guidance documents and training curricula for external study team such as contributing CRO and consultant personnel for processes and workflows associated with the eClinical system in collaboration with internal functions and with the eClinical vendor

EClinical System Framework:

• Lead system standard team(s); assure compliance with standard governance processes established for eClinical system.

• Partner with functional Managers/Directors within Clinical Development to establish and maintain requirements, processes and study tools that impact cross functional use within the eClinical system.

• Serve as the primary lead/contact with the vendor and internal stakeholders for the general management of the eClinical system.

• Develop and maintain eClinical system user roles and provide oversight for global access management. Manage process for assigning eClinical system roles for the studies as it pertains to CTMS and eTMF and performing periodic review of accounts for removing access due to study end or personnel changes.

• Serve as the subject matter expert for the eClinical system, understanding the baseline approach to configuration and supporting study teams to develop and execute module builds.

• Drive the study teams to maintain study and program timelines specific to eClinical System related activities.

• Build and foster third party resource/vendor relationships between eClinical system vendor and relevant study vendors.

Reporting:

• Establish reporting requirements for the eClinical System Governance Board with appropriate stakeholders.

Leadership:

• Orient and mentor Clinical Development team members in the use of the eClinical System
• Provides input to strategic decisions that affect the functional areas of responsibility across the eClinical system
• Collaborate working across the subsidiaries of Emergent on corporate initiatives; fosters a culture of cooperation and harmonization.
• Enable building of potential strategic partnerships/networking relationships with consultants and potential outsource providers for clinical development programs or associated expertise.
• Resolve escalated issues arising from operations requiring coordination with other functional departments.
• Support Emergent corporate initiatives by modeling employee engagement and openness to change. Assigns appropriate resources to bring appropriate training and mentoring into the department during implementation.
• Collaborate working across the subsidiaries of Emergent on corporate initiatives; fosters a culture of cooperation and harmonization.
• Represent Clinical Management interests in corporate and cross-affiliate Operational Excellence initiatives, as assigned.

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, Knowledge & Skills

• The Completion of a bachelor's degree, preferably in Life Sciences, accompanied by 5-7 years' experience (or an equivalent combination of education and experience), in pharmaceutical or biotech industry working in any of the following areas: clinical study management (within electronic systems), project management, vendor relationship management, or procurement.
• Direct experience in implementing and administering electronic clinical management systems.
• Direct experience in managing successful teams is required to effectively communicate goals, motivate team members, and overcome obstacles.
• Demonstrated competence in building high performing teams.
• Extensive knowledge and understanding of ICH and regulatory requirements and procedures applicable to Clinical Research.
• Demonstrated success in setting and achieving results within budget and timeline specifications.
• Excellent analytical, leadership, problem solving, written/verbal communication, computer and interpersonal skills required.
• Strong organization and attention to detail.
• Proficient in MS Office Suite.

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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