Global Data Manager at Pharmaceutical Research Associates, Inc.

Posted in Information Technology 7 days ago.

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Location: Raleigh, North Carolina





Job Description:

Pharmaceutical Research Associates, Inc.

Global Data Manager

US-Remote
Canada-Remote


Job ID: 2020-64363
Type: US-Southeast
# of Openings: 1
Category: Data Management

Janssen

Overview

Global Data Manager

Strategic Solutions (SSD)

Who we are:

Over 525 PRA Biometrics resources currently in FTE Programs across 12 global clients

86% global team retention (well above industry standard)

Resources located in North America, South America, Asia-Pacific and Europe

Roles include embedded, dedicated leadership structure + all levels of Data Managers, Stats Programmers, Biostatistics, IVRS, ePRO, Medical Coding

Several teams are remote, others partially based in PRA Philadelphia headquarters, others at Sponsor sites, global PRA facilities

Management almost always grown from within, with a PRA manager in place for every team

Teams range in size from 1 resource to 200+ and several relationships have been established for 5, 10, and 15+ years!

Our motto: One client! One team! One set of processes to learn!

Why join SSD Biometrics?

PTO policy is very competitive

Employee Stock Purchase Plan

Have you had a chance to see our sweet office in Blue Bell?

Significant return rate of PRA ex-employees

Get involved in client initiatives, process improvements, investigator meetings, training, mentoring…..break out of the day-to-day

See the results of your work through direct discussions, meetings, townhalls and teambuilding events with client leadership

Upward mobility for those that are interested – our SSD leadership structure is primarily built from within and have been in place with us for 5, 10+ years!

High retention of team members and management means stable teams and positive program culture

Permanent PRA employees with examples of opportunities to convert to client perm roles

Significant global industry conference participation, SCDM, JSM, PhUSE, PharmaSug, DIA.

Overview:

Provides data management oversight and accountability for one or more clinical trials.

Responsibilities:

Takes a leadership role with the CRO, the trial customer(s) and other internal and external partners to establish, align and confirm data management expectations for assigned trial(s).

With the trial customer, CRO and other functional partners: – Gathers content and integration requirements for eCRF and other data collection tools. – Establishes conventions and quality expectations for clinical data. – Establishes expectations for dataset content and structure. – Set timelines and follow-up regularly to ensure delivery of all Data Management milestones.

Performs trial level oversight controls as described in the oversight plan, QC process and work instructions with minimal DML direction.

Reviews clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency. Ensures compliance with regulatory guidelines and the documentation matrix.

Ensures real-time inspection readiness of all Data Management deliverables for the trial; Participate in Regulatory Agency and J&J internal audits as necessary.

Plans and tracks content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival. Ensures deliverables are on time.

Takes a leadership role with the assigned clinical working group(s) to ensure that Data Management and TA trial needs and deliverables are met.

Identifies and communicates lessons learned, best practices and frequently asked questions at the trial level.

Presents and trains at investigator and monitor meetings if needed

Qualifications:

High school diploma with relevant experience required. Bachelor’s degree or equivalent in Health or Science discipline, with experience in clinical research, desired.

Minimum of 5 years of Data Management experience (start-up to lock).

Clinical trials experience is required. Experience managing multiples studies at once with experience managing competing priorities is needed.

Oncology experience is helpful. But, not required.

Experience working in highly diverse teams within clinical research; cross-functional, global, multi-regional.

Project management skills. Must have prior experience creating timelines and managing deliverables.

Vendor management skills.

Advanced Microsoft Office skills including the ability to manipulate and analyze data.

Must have experience reviewing SAS and SDTM datasets.

Experience with RAVE is highly desired.

Highly organized with excellent written and verbal communication. Must have experience presenting during kick-off meetings, investigator meetings, and study team meetings.

Ability to interpret clinical trial data and present trends to clinical trial team on data.

Very minimal, if any, travel is expected. Possibly for investigator and/or kick-off meetings.

To qualify for a role located in the U.S., U.S. applicants must be legally authorized to work in the United States, and should not require now or in the future, sponsorship for employment work visa status.

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

PI121240985


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