Rave Solutions Architect/ EDC Clinical PM-----REMOTE

Greetings,

Hope you are doing great!!

This is Gurpreet Singh from EHUB Global. Please send me the updated resume with your salary expectation for this potential opportunity.

Position: Rave Solutions Architect/ EDC Clinical PM

Location: Remote
Type: Fulltime

This position will be for a hybrid role comprising Rave Architect, Electonic Data Capture (EDC) platform technical expert and Clinical Technical SME/Manager He/She self will be responsible for the implementation of technical projects and management of day-to-day platform activities and should have a strong technical knowledge with leadership skills including but Iimited to cross-departmentally engagements, ability to motivate team members and to partner with the EDC product vendors to ensure delivery The candidate should be a technologist with a desire to lean and adapt to a changing technology ecosystem.

Technical Manager driving automation initiatives, prototyping process

standardization and data management Defines and implements EDC solutions, performs Risk analysis and mitigation plans

with provided timeframe and upraises the project stakeholders. Gather cross functional input and drive implementation of technical decisions

Provide oversight Implement EDC Core Configurations (elevating. Mapping including roles, permissions, and functionality settings)

and implement Design and imp sensitive alert notification system(x) Ensure programs

are monitored. Design and implement Custom scripts, reports, and datasets.

Collaborate on data integrations with internal applications 3rd party vendors.

implement data lakes by providing expertise on data design and review of API and web-service calls.

Advise on validation scenario testing for EDC configuration changes and provide sights on defect fixes, and software enhancements

Identify technical issues that support critical business processes, Facilitate rapid issue resolution by working with vendors and internally to resolve issues, provide technical troubleshooting expertise and impact evaluation with multiple stakeholders

Build effective relationships and partnerships within the Programming, Analytics & Solutions Department, Global Development Operations (GDO), Global Statistical. Programming, Global Safety, IS Quality and Compliance

Provide stady-level support on assigned studies for SAE integration and script execution

Support development/maintenance of 50Ps processes, templates and standard methodologies and GvP documentation

Assist in preparing for Audit and responding to audit findings (internal or external).

Delegate tasks to assigned staff, FSP, or contractors that support larger deliverables and projects.

Provide training and mentorship to team members

Knowledge

Knowledge of EDC areas including study design, programming coding, role/user

management, report development, and data exports Knowledge of Decentralized clinical trials and emerging automation technology in the pharmaceutical/biotechnology industry

In-depth knowledge and hands-on experience in developing complex Business Rules, study structure and EDC applications (eCOA/ePRO, iMedi-data, Cloud Admin, Balance RTSM, CTMS, Coder, Grants Manager, MML, RSR, Consent, Safety Gateway, End of study, TSDV, Monitor)

Acquaintance of one or more of the following EDC Clinical Systems such as Medidata Rave, Veeva EDC, Oracle Clinical, Medric, InForm, etc,

CTMS Systems such as Siebel CTMS, Medidata CTMS, Veeva CTMS, etc,

IRT Systems

LAB Systems such as central Lab, local Labs etc.,

Good understanding of clinical trial domain & overall EDC study setup & reporting process

Experience with Agile Working Environment

Experience with visual and analytical reporting to support trial performance and data activities

Experience with validation documentation and standard methodologies

Working knowledge of data management

Experience authoring work instructions and guidance documents

Experience with internal and external inspections

Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and

applicable international regulatory requirement

EDC Tools Medidata Rave, Veeva EDC, OC/TMS, InForm

CTMS Systems-Siebel CTMS, Clinical Vault, Medidata CTMS

In-depth knowledge of CDASH and SDTM

Expert in CF, 804 reports, SQL

Management Skills Marrage the projects through SmartSheet, JIRA commitment to timeline management.

Experience in programming language such as Java

Experience with data sharing mechanisms (e.g. APL RWS Calls, FTP)

Mandatory Agile methodology and process knowledge, including Jira, Confluence, Retina

Preffened Qualifications:

BA, B5, MS degree in the life sciences, computer science, business administration or

related field Strong understanding of the concepts of clinical research and drug development

14+ years of experience in technology within the life sciences at a software, biotech pharmaceutical or CRO company

Knowledge of EDC platform configuration settings.

Experience with EDC safety module configuration/setup to electronically transfer SAE

Working knowledge of E2B guidelines and implementation

Experience with other clinical trial technologies (RTSM/IVR CTMS TMF PRO COA, Argus) along with integration design practices

Hands-on experience working on various EDC tools/system

Strong knowledge of ICH/GCP guidelines, Familiarity with FDA regulations such as 21

CFR Part 11 and Gal

Hands-on experience developing applications and/or notification systems Experience working with all phases of SDLC

Best Regards

www.ehub.global

Gurpreet Singh
Account Coordinator

Ehub Global

M: 214-751-8342

gurpreet.s@ehub.global

17304 Preston Road Suite 800, Dallas, TX, 75252

USA | COSTA RICA | CANADA | INDIA

Ehub Global provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. We especially invite women, minorities, veterans, and individuals with disabilities to apply. EEO/AA/M/F/Vet/Disability.