COMPLETE Clinical Data Management - Team Manager - Vaccine - Swiftwater, PA

Job Summary

The CDM Team Manager is responsible for the oversight of a team of Clinical Data Managers and all their clinical trial activities and deliverables as well as their transversal activities.

The CDM Team Manager role requires a thorough understanding of clinical data, efficiencies in guiding its collection, development/maintain data acquisition standards to ensure quality and regulatory compliance, oversight of its management and assurance of its integrity in the clinical trial process.

The CDM Team Manager is responsible for managing, coaching, and developing employees to develop operational excellence through ongoing training of internal data management employees and/or consultants.

Key Responsibilities

• Ensures that, within his/her CDM team, clinical trials are compliant and documented as appropriate within the company operating procedures and regulatory guidelines.

• Ensures that, within his/her CDM team, the integrity and quality of the data that can be provided to Health/ Regulatory authorities for submission.

• Ensures an efficient implementation and follow-up of CDM activities within the partnerships for outsourced trials. Also participates in the oversight of communication, planning, resources within the partnership in collaboration with the Partnership Manager.

• Participates in the overview of Standards activity to support the definitions and updates of Standards interacting with Standard Manager.

• Follows the Key Metrics within the CDM platform for internal/outsourced trials and ensuring/supporting Major Milestones achievements in a timely manner.

• Works in collaboration with Clinical Department, to contribute to budget, priorities and to allocate resources to projects in development and to support needs at clinical team level.

• Participates in the strategy/orientation definition of Data Management activities and related environments within the company.

• Works in close collaboration with Global Head CDM for budget review, resource allocation and CDM overall strategy support.

• Responsible for identifying, participating, and overseeing transversal initiatives concerning continuous improvement.

• Responsible for representing CDM both internally and externally, and for analyzing current operating techniques to insure optimal usage.

Requirements & Qualifications

• Master’s Degree in Health/Life Sciences, Computer Sciences, or other related area.

• Minimum 10 years of relevant industry experience – in CRO or Pharma. Minimum of 10 years of experience in data management in clinical/medical field.

• Minimum of 5 years of experience in people management.

• Extensive knowledge of data management software and computing skills (e.g. Rave, EDC systems, eCOA, SAS, Data visualization)

• Extensive experience with process development within data management

Skills

• Fluent in English

• Ability to work in a multi-cultural environment

• Effective management skills

• Team spirit, active listening, ability to lead working groups

• Ability to network and communicate with various functions

• Experience with audit and inspections

• Excellent communication and organization skills

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#GD-SP
#LI-SP

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.