Clinical data management manager job description

About Ferring:
None of our ambitious plans for the future can be realized without research. We believe in the power of discovery and the need to go where research takes us. We're passionate about discovering new therapies that benefit patients and their families. This spirit helps us create a rich product pipeline and a growing portfolio. For us, research means impact. We're impacting millions of patients and families that benefit from our treatments and medicines, as well as the caregivers, providers and healthcare professionals who make it a priority to take care of them every day. Join our curious team and pursue career-changing opportunities.
Job Description:
Contribute to outstanding innovation + Make braver choices

Manager, Clinical Data Management
Location: Parsippany
As a privately-owned, specialty healthcare company, Ferring focuses on developing life-changing innovations that help people 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 commitment to science and research, Ferring is relentless in 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.Summary:

The candidate will be responsible for data management in clinical trials across all therapeutic areas as Lead Clinical Data Manager.
Setups and maintains clinical data management processes and data capturing systems for clinical trials by following Ferring SOPDevelops CRFs, 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 the biometrics team including biostatisticians and statistical programmers to ensure quality deliverables. The candidate participates in departmental process improvement and standard development initiatives.

Responsibilities:
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 project level standards for data collection and data handling.Participates in selection of data management vendors and ensure quality and performance of vendors.Leads/participates in development and implementation of advanced/innovative clinical trial processes.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.

Requirements:
Master's or bachelor's degree in life science, computer science, or related discipline, or diploma for clinical data management or equivalent.At least 5 years' experience of clinical data management in pharmaceutical, biotech, academic, or CRO setting.Experiences with SAS programming is preferable.Knowledge of CDISC data standards, preferably with experiences of implementation.Fluent in written and spoken English.Budget/Revenue (annual turnover accountability, annual cost or project budget the role has at its disposal).
Prospective new hires for this position must be fully vaccinated against COVID-19 as a condition of employment. Vaccine verification will be required on your start date unless an exemption has been approved by the Company as a medical or religious accommodation.

Join our team and you'll become part of a close-knit family - one in which you'll be listened to and your contributions valued. Surrounded by like-minded people, you'll have the support to achieve more. So if you love to come up with new ways to make a positive difference and see them through, welcome to the team.We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/ProtectedVeterans/Disabled. We maintain a drug-free workplace and perform pre-employment substance abuse testing.

Location:
Parsippany, New Jersey

The Manager, Clinical Data Management provides oversight of lead Data Manager(s) on assigned clinical data management projects in multiple therapeutic areas to assure proper planning and execution for data management deliverables that meet Regeneron standards and within timelines. Ensures training when there are direct reports to ensure they have adequate data management skills and are in compliance with all regulatory requirements. Coordinate with Director or Associate Director of Data Management in the development of SOPs, Working Practice, Data Management Manual, and other data management standards.
A typical day might include the following:

•Serves as primary DM contact for assigned therapeutic areas to interact with clinical counterparts for overall project planning and issue resolution. Projects, allocates and prioritizes DM resources within the assigned therapeutic projects.

•May supervise direct DM reports for planning and managing all relevant DM activities within the assigned therapeutic areas for timely and quality deliverables and within the budget. Mentor junior data managers for skill set advancement. If required, leads and performs clinical data management tasks for studies.

•Supervises and ensures all databases are developed, validated and ready for transfer and/or analysis according to policies and procedures, SOP's and work instructions in compliance with applicable regulations.

•Reviews and approves for final archival of project documentation, including, but not limited to, Data Management Manual, CRF Completion Guidelines and validation specifications, and work instructions for assigned projects. Designs and modifies CRF.

•May supervise DM direct reports for the initiation and approval of the building, and validation of clinical databases, subsequent changes in clinical databases and data validation activities. Coordinates with clinical project team for issue resolution.

•Contributes to development of Regeneron DM outsourcing strategies and long-term relationships with outsourcing partners with objective of ensuring data quality and efficiencies through data and process standardization.

•Ensures adequate management of CROs and vendors in the therapeutic projects and coordinates all data management functions.

•Establishes goals, expectations and accountabilities for direct reports. Regularly reviews DM performance in respect to quality and timeliness standards according to Regeneron SOPs and working procedures. Responsible for coaching, managing training and leading the direct reports.

To be considered:

Bachelor's degree in mathematics, Science or a related field, along with at least 8 or more years of clinical data management experience in biotech, pharmaceutical or health related industry. Previous oncology and/or ophthalmology experience a plus. Previous managerial experience is preferred Directed and comfortable working in teams with the ability to work and operate independently within a tight deadline environment. High degree of creativity, latitude and attention to detail required. Knowledge of all applicable regulations including; CFR, GCP, and ICH Guidelines. Strong communication, leadership and business development skills required. Proficient with appropriate EDC applications and Microsoft Office applications. Software proficiency with CDMS required. Experience with JMP and SAS a plus.


Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

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VIPcare is a quality based healthcare organization that focuses on prevention. We encourage four well visits per year, proactive outreach to our most fragile and at-risk patients, same day urgent appointments and transitional care management.

THE OPPORTUNITYThe Risk Manager at VIPcare/SaludVIP will lead and support the development, implementationand maintenance of all activities related to clinic quality, safety, and risk. The team member willimplement, oversee, monitor, enforce and, when necessary, modify the Clinic Quality/ Safety/Risk Programs. The role will work with the Compliance and Health Services Teams todevelop written standards and procedures, conduct internal auditing and monitoring, providestaff training and education, investigate possible violations, develop corrective action plans andwhen appropriate, enforce disciplinary standards. Reports directly to the Chief Compliance Officer and works collaboratively with cross functional leadership. The Risk Manager will understand regulatory standards and help develop internal procedures and guidelines. The Risk Manager will play a vital role in establishing and supporting the entire team's compliance for clinical and medical procedures in order to address and reduce potential safety, financial, and patient concerns. Responsible for risk management, oversight of qualitycontrol measures, and understanding applicability of regulations, the Risk Manager conductsverifications and audits to provide requested performance reporting and guidance oncompliance and risk management matters.The Manager of Clinical Risk Management & Safety will assist the Compliance Officer with compliance, risk management, and quality improvement initiatives, including required trainings, assessments, corrective actionplans, and collaboration with all teams and/or third parties to make sure all levels of business stay on ethical courses and within the guidelines of applicable corporate and regulatory requirements.

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• Experience working in the clinical quality/risk/safety/ or compliance functions in a multi-provider, multi-location medical group practice

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