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SalaryA Career with Purpose
Bionical Emas is a global Clinical Research Organization (CRO) bringing life-changing medicines to patients around the world. We combine Clinical Development, Clinical Trial Supply (CTS) and Early Access Programs (EAP) to deliver a unique, seamless service to our pharma and biotech clients.
At Bionical Emas, you will have the chance to develop your career while working with an outstanding team of people. Our shared values create a unique culture that guides our actions and defines who we are. You will be a part of a welcoming, flexible, and supportive culture that values trust and belonging. We believe that creating opportunities for our people to develop their skills is crucial to our growth and success. If you are inspired by changing the lives of patients all over the world, we’d love to hear from you.
About the Role
The Lead Clinical Programmer oversees the creation and upkeep of data quality standards, conducting programming and validation tasks to enable routine and on-demand quality control in clinical studies. This position will support the clinical study team by identifying, specifying, and implementing relevant listings and reports to ensure the attainment of sufficient quality in clinical trials.
What will your job look like?
- Build, maintain, and lock databases
- Build and execute programs for data review, reconciliation, and edit checks
- Develop and maintain clinical programming standards and tools
- Cooperates with study teams to ensure study reports are implemented, maintained, and correctly processed on study platforms to help them efficiently lead their projects
- Collaborates with study teams to ensure the submission readiness of clinical data and supports the review of related deliverables
- Partner with Lead Data Managers to ensure studies are built, maintained, and locked on time while accurately reflecting Sponsor’s data capture requirements
- Participate in required audit activities for internal Quality Assurance (QA), Sponsor, Regulatory, and third-party vendors
- Independently partner and manage Data Management resources, per study requirements
- Collaborate with cross-functional internal stakeholders requiring data management expertise
- When delegated, independent support with all aspects of RFP tasks; serve as a point of contact for RFP documents and pricing, attend in-person/virtual bid defence meetings
- Provide data management expertise, knowledge, and best practices in the development and/or maintenance of SOPs and WI
What will you need to succeed?
- Bachelor’s or Master’s degree, along with or an equivalent related experience in a comparable data management and/or research field
- A comprehensive proficiency within multiple EDC platforms (Medidata Rave, Zelta, Veeva, or Medrio)
- Thorough understanding of data management processes and standards, including day-to-day administrative processes
- Enhanced expertise in regulatory guidelines/requirements (ICH/GCP, EMA, FDA)
- Familiarity with CDISC Standardization
- High level of proficiency in the analysis and processing of large amounts of technical, clinical study data
- Ability to utilize strong interpersonal skills in combination with critical thinking and problem-solving abilities, especially under pressure
- Ability to complete multiple deadlines/tasks on a variety of deliverables
What will you get in return?
We want you to do your best work! We care about our people’s well-being, their personal development and providing a true work-life balance. Our benefits are aligned with our culture and values and are intended to maximize your experience working for us. Here are some of the benefits you can expect from working for Bionical Emas.
- 25 days of vacation
- Vacation days purchasing scheme
- 1 extra vacation day per each 3 years of service
- Discretionary Annual Bonus
- Sabbatical of 3 to 6 months (after 2 years of service)
- Free food and beverages at all offices
- Life Insurance
- Health Insurance and Employee Assistance Programme
- Employee Support Networks – help us continue to build on our inclusive culture
- Flexible and hybrid work
Does this sound like you?
It is time to apply, and we can’t wait to hear from you!
Even if you don't meet 100% of the requirements, be confident in yourself and don't hesitate to apply!
PLEASE NOTE: We will be longlisting applications as soon as we receive them, so please apply early to register your interest.
We Are Bionical Emas
We are proud of our people and proud of our achievements. We encourage and hire people with diverse backgrounds, voices, beliefs, and perspectives into our growing global workforce. We do not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state or local laws and ordinances. Bionical Emas’ management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment.
Bionical Emas offers equal opportunities and is committed to diversity in its workplace and providing accessibility accommodations to applicants with physical and/or mental disabilities. If you are interested in applying for employment with Bionical Emas and need accommodation or special assistance, please let us know by sending an email with your request to the recruitment team at HR@bionicalemas.com.
We Are Bionical Emas, where each person is unique. We celebrate individuality while encouraging our talents to work as a team. Together, we make a difference by powering an inclusive future for all. Be you, with us.
Protecting your privacy and the security of your data is a longstanding top priority for us. Please consult our Privacy Notice to know more about how we collect, use, and transfer the personal data of our candidates. Our Privacy Notice explains what personal information we may process, where we may process your personal information, our purposes for processing your personal information, and the rights you can exercise over Bionical Emas’ use of your personal information. By applying for the above position, you confirm that you have reviewed and agreed to our Data Privacy Notice for Candidates: Privacy Policy - Bionical Emas applicable to your place of residence.
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