Clinical Solution Analyst
4 weeks ago
Primary Purpose / Regulatory Responsibilities:
A primary function of this position is to globally provide skilled Key User oversight of clinical
applications and data repositories, including system upgrades and change requests to be
implemented on timely manner and within budget.
The further key function of this position is to lead the implementation of data collection and
management solutions for clinical studies, ensuring appropriate requirements gathering,
specification, selection and implementation.
Responsible for the oversight and management of Key User support for clinical
applications, system integrations, and data repositories. Systems may include:
- Clinical Trials Management System (CTMS); Business Intelligence (BI) and
dashboards for CTMS; electronic Trial Master File (eTMF); Electronic Data
Capture (EDC)/ Thesaurus Management System (TMS) and underlying systems;
Clinical Ourcome Assessment Repository (COAR); Metadata Repository (MDR);
Clinical Data Repository (CDR); Electronic Document Management System
(EDMS); and others
Oversee system upgrades and change requests and work in collaboration with
Information Technology (IT) in the System Development Life Cycle (SDLC) from
feasibility, gathering requirements to implementation, training and maintenance
Define the expected business outcomes that are supported by the application and any
required integrations including expected service level agreements.
Prioritize IT support, projects, change requests, and support the process of collection
and consolidation of projects in line with Global Clinical Sciences and Operations
(GCSO) and *** s strategy with regards to IT project/budget planning.
Act as delegate of the Process Data Owner (PDO) in the creation, review, and approval
of system documentation.
Ensures delivery of clinical solutions to collect and manage data in studies.
Works with external stakeholders (e.g., Clinical Research Organization (CRO)) and
clinical teams to ensure successful implementation and maintenance of solutions for
data collection and management within studies.
Provide operational data reporting and data discovery dashboards for review and
analysis to support Clinical Teams on identifying data related issues, review
study/program metrics, and provide an overview of cross-projects/trials analyses for
various functions including Patient Safety, Patient Value Units and senior management
as required.
Provide skilled business advice on the selection of new clinical technologies in line with
*** s strategy by evaluating new technologies and their potential use while assessing
the business risks and benefits.
Participate and may lead workstreams/taskforces to define the usage of clinical
applications and business processes to achieve efficiencies and synergies in system
support, eliminating redundancies and streamlining activities.
Responsible for training the Super Users/Advocates to be experts and knowledgeable
in clinical applications and have oversight of their support. Manages and leads the
User Group/Stakeholders meetings and discussions ensuring alignment across
departments.
Provide training, mentoring, and guidance to new team members as needed.
Support audits and inspections as required and other responsibilities and projects that
the Company may assign.
Specific skills
Strong computer proficiency, especially in use and management of databases and
generating reports.
Ability to work cross-culturally and provide skilled leadership/guidance to teams
located worldwide.
Advanced written and verbal communication skills. Strong communication skills with
all levels of personnel globally, interpersonal skills and the tact and discretion required
for negotiation within a global team setting to obtain cooperation and approval from
other team members. Must be able to effectively organize ideas for logical
presentation and acceptance.
Experience in leading and participating in collaborative work teams at local and global
levels.
Experience in managing multiple tasks, projects and personnel concurrently.
Self-motivating with the ability to work without supervision.
Project management skills.
Proficiency in English.
Good organizational skills, problem solving skills, and supervisory skills.
Ability to engage and motivate application users.
Experience in engaging key stakeholders and customers to influence and achieve
optimal business objectives and to promote strategic initiatives.
Problem solving
Proactive problem solver, uses initiative, identifies problems and/or opportunities for
improvement and proposes workable and acceptable solutions.
High levels of initiative, drive and commitment with an ability to adopt an
entrepreneurial and innovative style when required.
Open minded, with ability to understand conflicting issues and priorities, and negotiate
acceptable resolutions, across functions.
Able to adapt to change and champion the change.
Able to plan, perform, trouble-shoot and make decisions based on precedent, company
policies, *** procedures, international and national regulations and Good Clinical
Practice (GCP)
Ability to work accurately and efficiently and when necessary create new processes and
procedures.
Experience in evaluating system reports and Service Level Agreement (SLA) reports to
detect potential problematic issues.
Ability to manage uncertainty.
Must be creative and develop cost-effective solutions in an effort to maximize
efficiency and achieve success when confronted with limited resources.
Experience Without, at
least, a
Bachelor s
degree
With, at least, a
Bachelor s
degree
Pharmaceutical/CRO setting. 9+ years 7+ years
Relevant experience in the clinical data / technology field in Drug
Development or Life Sciences working with EDC, CTMS, TMF, MDR,
CDR, COAR, BI reporting/dashboards, system integrations, and other
systems.
7+ years 5+ years
Good Practice (GxP) and system validation experience. 7+ years 5+ years
Knowledge of clinical processes and technical framework.
Previous experience creating new processes, Standard Operating Procedures (SOPs) and related
documents.
Knowledge of federal regulations, Good Clinical Practice, and Good Clinical Data Management
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