Job Description

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.

MAJOR RESPONSIBILITIES

• 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.

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 company 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

U’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, company 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.

 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 Practices.

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