Job Description

Primary Purpose / Regulatory Responsibilities:

The primary function of this position is to globally provide oversight of clinical applications and

data repositories, to assist internal and external users with data quality and completeness,

and to support system upgrades and changes.

Major Responsibilities

Responsible for the oversight of clincial applications, system integrations, and data

repositories. Systems may include:

o 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

Data Repository (CDR); Electronic Document Management System (EDMS); and

others

 Assist with 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.

Document the expected business outcomes that are supported by applications and any

required data integrations, including expected service level agreements.

 Collaborate on planning and prioitization within Global Clinical Sciences and Operations

(GCSO) and with IT.

 Act as delegate of the Process Data Owner (PDO) in the review and approval of system

documentation.

 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 advice on the selection of new solutions in areas of own in line with company

strategy by evaluating new technologies and their potential use along with 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.

 Lead User Group/Stakeholders’ meetings and discussions ensuring alignment across

departments.

 Provide training, mentoring, and guidance to 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,

navigation of clinical solutions and generating reports.

 Ability to work cross-culturally and provide support and 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 and problem-solving skills.

 Ability to engage and motivate application users.

 Experience in engaging key stakeholders and customers to influence and achieve

optimal business objectives.

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

 5+ years pharmaceutical/CRO setting.

 At least 3 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.

 3 years Good Practice (GxP) and system validation experience.

 Knowledge of clinical processes and technical framework.

 Previous experience creating new processes, SOPs and related documents.

 Knowledge of federal regulations, Good Clinical Practice, and Good Clinical Data Management Practices.

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