For the past 20 years ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech med device and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization) ProPharma partners with its clients through an advisebuilrate model across the complete product lifecycle. With deep domain expertise in regulatory sciences clinical research solutions quality & compliance pharmacovigilance medical information and R&D technology ProPharma offers an endtoend suite of fully customizable consulting solutions that derisk and accelerate our partners’ most highprofile drug and device programs.
Due to growth we are looking for a Senior Clinical Programmer to lead on multiple studies for a client FSP.
Essential Functions
Acts as the Lead Clinical Programmer for one or multiple studies for a client FSP.
Complete Clinical programmer tasks for assigned studies under minimal supervision according to the study contract and applicable SOPs.
Design develop implement maintain and support clinical database systems.
Offer technical expertise for internal and external clients.
Code test and document databases as per programming standards and clinical validation policies.
Program database manipulation and conduct data transfers for clients.
Review Data Validation Plans and Case Report Forms as per area of expertise.
Add all external data sources such as PK and central lab within the clinical database if integration is requested or required.
Serve as programming contact to handle database issues within area of expertise.
Support development and implementation of new technologies.
Support Information Technology to evaluate new technology upgrades by participating in software change controls.
Support development revision and maintenance of core operating procedures and working instructions pertaining to database. development user acceptance testing and change controls.
Interface with project team to organize responsibilities and deliverables.
Establish effective communication and professional relationships with teams and external vendors.
Interface with Clinical Data Management and corporate team to negotiate timelines.
Perform administrative tasks within the EDC system such as site and user management URL level reviews and/or approvals and dictionary updates.
Follow and influence the development of data standards and strategies pertaining to the standards library.
Necessary Skills And Abilities
RAVE certification would be advantageous however we will consider applicants with a solid understanding of RAVE principals
Understanding of the principles of ICH GCP and regulatory requirements is essential.
Excellent organizational and analytical skills strong oral and written communication skills and able to work in a high paced timeline driven setting.
Educational Requirements
Minimum BS in a scientific or health related field or equivalent in years of experience.
Experience Requirements
Minimum 5 years of experience as a clinical database developer with at least one year of experience leading a study build.
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity equity and inclusion. Employees are encouraged to unleash their innovative collaborative and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer we provide a safe space where all employees feel empowered to succeed.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please no phone calls or emails to anyone regarding this posting.***
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