Principal Data Manager

Date: Oct 13, 2024

Department: Global Clinical Development

Job Type: Direct Employee

Team: R&D, Pharmacovigilance & Regulatory Affairs

Contract Type: Permanent

Location:

Cary, NC, US

About us

Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group research, develops and markets innovative drugs in its three therapeutic areas: AIR (products and services that promote respiration, from new-born to adult populations), RARE (treatment for patients with rare and ultra-rare diseases) and CARE (products and services that support special care and consumer-facing self-care).
We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes transparent ethical behavior at all levels.
We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.

Chiesi USA

Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets. We are a B Corp™ and Benefit company awarded Top Employer status for six consecutive years and certified as a Great Place to Work.
At Chiesi, we share an entrepreneurial spirit and act as a force for good, pursuing high social and environmental standards, to ensure the wellbeing of our people, patients, and communities. We offer a work environment where professionals have the opportunity to build a purposeful career focused on helping others while achieving a fulfilling work-life balance, meeting exciting challenges, and engaging in important and rewarding work.

What we offer

Chiesi offers competitive benefits, services, and programs that enrich the personal and professional lives of our employees. Our shared values of passion, innovation, trust and integrity bring out the individual talents and diverse perspectives of each of our colleagues. Our environment encourages each individual to reach his or her full potential and drive outstanding results. We celebrate that “Every one of us is different. Every one of us is Chiesi."

Purpose

To lead data management activities of the assigned project(s) ensuring data strategy and data governance are properly implemented across all clinical studies
To act as technical leader supporting team members, ensuring consistent data management approach across studies, and representing data management at project level
To ensure technologies/systems/data platform needed for collecting and handling clinical data are properly developed, tested, fit for purpose and integrated
To ensure data management activity of the assigned projects are planned and executed according to project timelines, with highest standards in data integrity and data quality and under budget control
To define the strategy for data submission and lead the preparation of the data package to be submitted for drug approval
To represent Data Management in case of audit and Regulatory Inspection

Main Responsibilities

To plans and drive the conduct of all Data Management activities for the assigned project(s) ensuring consistent approach across studies
To manage high complex studies and/or support specific activities of studies managed by other data managers or consultants
To provide technical tutoring and supervise data managers and/or contractors assigned to clinical studies of the project by conducting regular reviews of activity status
To manage and guide providers, setting requirements, preparing or reviewing Request for Proposals and monitoring performance
To regular monitor data management costs of the assigned studies ensuring respect of budget
To define and proactively manage risks with potential impact on study systems setup, study conduction, or reliability of study results
To ensure all data collection systems for assigned projects are setup, tested and fit for purpose according to expectations and timelines
To lead the data quality evaluation, by the investigation of all clinical and operational data, evaluating trends, deviations, using visual analytics tools and ad hoc reports
To define the strategy and lead the preparation of data package for regulatory submission
To represent data management for auditing / regulatory inspection

Additional responsibilities ad hoc:

To act as Subject Matter Expert on Digital technology applied to Data collection, RWE studies and de-centralized trials.

Experience Required

Minimum 10 years of experience in Clinical Data Management in CROs or Pharmaceutical Industry
Solid knowledge of drug development processes
Strong data management expertise
Excellent knowledge of Good Clinical Data practices, GCP and regulatory requirements
Experience of clinical databases, electronic data capture (EDC) systems, wearables and sensors to collect data directly from patients
Excellent knowledge of Risk-Based approach
Knowledge of Real Word data sources and processes to collect/manage different type of sources (e.g. EHR data, data collected directly from patients, omics data, other secondary data)
In depth knowledge of Clinical Data Interchange Standards Consortium (CDISC) relating to data standards including Study Data Tabulation Model (SDTM) and Case Report Tabulation Data Definition Specification (Define.xml)
Advanced analytical and technical skills to interrogate and mine high volume of data from a variety of sources
Basic knowledge of Artificial Intelligence (AI)
Project Management
Excellence in planning and priorities setting
Analytical, problem solving skills and ability to take ownership of decision-making
Strong commitment to quality
Excellent oral and written communication and presentation skills
Ability to collaborate and work in a team-based environment
Courage, resilience, and ability to adjust to a rapid changing environment

Education

University Degree in Scientific Disciplines

Technical Skills

Medidata platform
Other platform for secondary data
SAS System

Chiesi USA is an equal opportunity employer committed to hiring a diverse work force at all levels of our business. All qualified applicants receive consideration for employment without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, veteran status, gender identity or expression or any other basis protected by local, state or federal law. This policy applies with regard to all aspects of one’s employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.