Manager, Clinical Database management – REMOTE

Why consider joining us?

As a member of our thriving team, you have the opportunity to work alongside clinical research colleagues who understand the patients’ mindset and their disease experiences.

We help translate science into success for trials with a strategic and targeted, patient-centric approach.

We are specialists who find solutions for novel trial challenges in our detailed approach throughout every study phase.

From the beginning, we have nurtured an employee-centric company culture that focuses on patients’ needs.

Precision’s team-focused culture ensures that team members will thrive and learn.

These important key elements result in high quality work output while still having fun and giving back to the patient community.
Position Summary
The Manager, Clinical Database Management is responsible for the design, development, testing, implementation, maintenance and support of clinical databases and software applications.

Will interface directly with the internal team (i.e.

Data Management, Project Management, etc.), EDC vendor, clients and third-party vendors to gather requirements and provide status updates.

Provides operational and technical training to end users and junior staff.

This position may also participate in software validation.

Manages the day-to-day activities of the Database Management function in accordance with Standard Operating Procedures (SOPs), regulatory directives; and study specific plans with an emphasis on effective resourcing and development of personnel.

Provides oversight and leading activities for database management projects; coordinates inter-departmental and client communication and helps resolve administrative, personnel, and database and/or applicable software-related issues.
Essential functions of the job include but are not limited to:
Oversees the full-scope of responsibility for assigned projects: ensures on-time delivery, communicates the status of projects to internal teams and study Provides input and guidance to the design of clinical databases to the client and internal teams Oversees the building and supporting of clinical databases Oversees the development, testing, and validation of application programs and clinical databases to support client-related projects and third-party applications.

May provide system administration and advanced technical support services for internally developed applications and clinical databases, client-related projects and third-party applications Troubleshoots and resolves software and clinical database problems Develops and maintains study-specific validation documents May provide data management support for client-related projects from CRF design to post database close and archival May design, develop and validate the Company’s internal applications, client-related projects and third-party applications.

Participate in software vendor selection Participate in conducting EDC demonstrations and trainings Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management, database management and applications development activities Provide technical and operational guidance and direction, checking output of project work, ensuring deliverables are met and performance and professional behavior management May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings Reviews Request for Proposals (RFP), proposals, provide project estimates Provide leadership for cross-functional and organization-wide initiatives, where applicable Ensures that all data management project team members have been sufficiently trained Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues Present software demonstrations/trainings, department/company training sessions, present at project meetings Provide technical guidance and advice to key senior leadership on reasonable growth and process goals to assure data quality Requires some travel May perform other duties as assigned
Qualifications
Minimum Required:
5+ years’ experience Bachelors and/or a combination of related experience
Other Required
Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.

Able to handle a variety of clinical research tasks.

Excellent organizational and communication skills Professional use of the English language; both written and oral.

Experience in Object Oriented Programming (C#, C++, VBS, etc.…), scripting language (PERL, etc..), SAS, R, SQL Experience in clinical database management system development.

Experience in a clinical, scientific or healthcare discipline.

Experience in utilizing various clinical database management systems Broad knowledge of drug, device and/or biologic development and effective data management practices Strong leadership and interpersonal skills Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…) 1+ years of leadership experience”
Preferred
Oncology and/or Orphan Drug therapeutic experience Experience in business development and producing cost estimates Base SAS®, SAS/STAT and SAS/ACCESS software SAS Macro programming language” Advanced experience in Database Management, object oriented programming
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