Manager, Clinical Data Management
As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our ‘people first’ philosophy. Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world’s oldest enemy: disease.
As the Manager, Clinical Data Management you will be responsible for data management in clinical trials across all therapeutic areas.
With Ferring, you will be joining a recognized leader, identified as one of “The World’s Most Innovative Companies” by Fast Company, and honored by Fortune with inclusion on its “Change the World List,” for addressing society’s unmet needs. Ferring US is also Great Places to Work® Certified, distinguishing it as one of the best companies to work for in the country.
Support and maintains clinical data management processes and data capturing systems for clinical trials by following Ferring SOP
Support CRFs development, data mapping specifications, DVP, DMP, and data transfer specifications and tests EDC system functionalities.
Participates in cross functional clinical trial teams and communicates data management matters effectively.
The candidate works closely with external vendors and the biometrics team including biostatisticians and statistical programmers to ensure quality deliverables.
The candidate contributes to departmental process, technical improvements and standard development initiatives.
Leads/participates in development and implementation of advanced/innovative clinical trial Processes and Technologies.
Contributes to development of Ferring data management team by coaching, mentoring, and supporting colleagues.
Leads/participates in projects within data management function.
Stays updated on data management technologies, tools, and solutions and share obtained knowledge within organization.
Responsible for all clinical data management activities in clinical trials in accordance with Ferring SOPs and current regulatory requirements.
Responsible for project management to ensure that all data management goals are met within clinical and project teams.
Develops and maintains standards and metadata repositories (MDR) to support data collection and data handling.
Participates in selection of data management vendors and ensure quality and performance of vendors
Master’s or bachelor’s degree in life science, computer science, or related discipline
At least 5 years’ experience of clinical data management or clinical data standards management or clinical data systems management in pharmaceutical, biotech, academic, or CRO setting.
Knowledge of CDISC data standards, preferably with experiences of hands-on implementation.
Good understanding of ICH-GCP and other regulatory requirements for clinical data submissions (eCTD).
Experiences with SAS and/or R programming is preferable.
Knowledge of systems integrations using APIs (Application Programming Interface) or webservices is added advantage.
Ferring + you
At Ferring, we offer competitive total compensation along with an exceptional range of flexible benefits, personal support and tailored learning and development opportunities all designed to help you realize your full potential both in life and at work. From working hours that respect your lifestyle, a culture that is welcoming and equitable, and the chance to work with the industry’s most impressive people, these are just some of the ways we live our "People First" philosophy.
Our Compensation and Benefits
At Ferring, base salary is one part of our competitive total compensation and benefits package and is determined using a salary range. The base salary range for this role is $122,500 to $227,500, which is the reasonable estimate of the base compensation for this role. The actual amount paid may differ based on non-discriminatory factors such as experience, knowledge, skills, abilities, education and primary work location. Additional compensation for this role will be provided based on competitive annual incentive compensation targets in the form of an annual bonus - payouts are based on individual and company performance.
Benefits for this role include comprehensive healthcare (medical, dental, and vision) with a premium differential, inverse to base salary, to be paid by employees, a 401k plan and company match, short and long-term disability coverage, basic life insurance, wellness benefits, reimbursement for certain tuition expenses, sick time of 1 hour per 30 hours worked, vacation time for full time employees to accrue up to 120 hours in the first four (4) years of employment, and 160 hours in the fifth (5th) year of employment as well as 12 to 13 paid holidays per year. We are proud to offer 26 weeks of paid parental leave, learn more about the parental leave offering in our benefits package here.
Ferring is an equal opportunity employer. All aspects of employment will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local laws.
Join our team and your voice will be heard, and your contributions will be valued. If you love to come up with new ways to make a positive difference and see them through, you will fit right in.
We are proud to be an Affirmative Action/Equal Opportunity Employer (including Disability/Protected Veterans). We maintain a drug-free workplace.