Associate Director, Data Management

Associate Director, Data Management - propharma group

Datum der Veröffentlichung: Jan 23, 2023

Auftragsdetails

Ort:

Western Springs, Illinois, United States of America
Gesellschaft:

propharma group
Typ:

Full Time/Permanent
Shift:

First Shift (Day)
Karrierelevel:

Experienced Professional
Positionen:

5
Erfahrung:

2 Year
Geschlecht:

Keine Präferenz
Grad:

Bachelors
Vorher bewerben:

Nov 30, 2023

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Job Summary

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Detailed Description

Job Description

Coordinate and manage the work of the assigned Data Management team.
Assist in resource planning, staff training, and direct reports’ performance reviews.
Develop strategies and support Data Management team to drive programs according to agreed timelines; if changes are proposed to agreed milestones and timelines, to assist Data Management personnel in evaluating the risk of these decisions and developing plans to minimize/mitigate these risks.
Accountable customer satisfaction and Key Performance Indicators related to Data Management deliverables.
Attend capability and defense presentations with clients to support the development of new business.
Attend RFI/RFP proposal strategy meetings and operationally lead strategy development and approve client proposals and budgets.
Work closely with Quality Assurance to ensure quality and continuous process improvement throughout the clinical and medical operations departments.
Acts as Project Leader, including primary Sponsor contact for all contracted Data Management activities and deliverables.
May act as Functional Lead for Data Management including primary contact for internal liaison between Data Management/Operations and Project Management, Clinical Monitoring, and other functional groups.
Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations.
Provides project specific training to internal and external audiences as required.
Responsible for financial management of assigned projects / programs, including revenue recognition, changes in scope and participation in internal project review meetings, including liaison with Finance group as needed.
Monitors and communicates project/program progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection and query management.
Plans, manages, and requests resources for assigned projects.
Develop and maintain project plans, specifications, and documentation in line with SOP requirements.
Participates in, and presents at internal, Sponsor, third-party, and investigator meetings.
Plans for and creates necessary documentation to support internal and external audits; participates in such audits.
Trains and mentors data management staff, acts as a subject matter expert.
Prepares input for and participates in proposal bid defense meetings.
Maintains proficiency in Data Management systems and processes through regular training. May attend/represent the company at professional meetings/conferences.
Maintains knowledge of regulatory guidelines and industry standards as applicable to clinical studies with specific emphasis on data management activities.
Provides input and maintains ProPharma Group SOPs as relevant to all data management activities.Performs other work-related duties as assigned.
Minimal travel may be required (up to 25%)

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

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Company Overview

propharma group

Berlin, Berlin, Germany

0 Aktuelle Stellenangebote

ProPharma Group is the leading global, independent, single-source provider of regulatory, clinical, and compliance services serving the pharmaceutical, biotechnology, and medical device companies. Our team of experts brings a comprehensive portfolio... Read More

Auftragsdetails