Lead/Senior Clinical Data Manager (offline)

We are seeking a highly skilled and experienced Lead/Senior Clinical Data Manager to oversee our data management operations. This role requires a proactive leader who can ensure accuracy and integrity in the data collection, processing, and reporting phases of clinical trials. You will play a critical role in the success of our trials and ultimately in the advancements in healthcare.


Key Responsibilities:
•Develop and implement data management plans to ensure the timely delivery of high-quality data for clinical studies.
•Design and validate clinical databases, including CRF creation, EDC setup, and data validation checks.
•Produce and review data listings, summaries, and reports for inclusion in clinical study reports.
•Perform data validation checks and enforce quality control measures to guarantee data accuracy and completeness.
•Develop and implement standard operating procedures (SOPs) for approval, data entry screen design and testing, and validation check testing and approval.
•Coordinate with cross-functional teams such as biostatistics, programming, medical writing, and project management to ensure cohesive data management strategies.
•Supervise, mentor, and lead data management staff to meet project milestones.
•Manage communications related to data management with internal teams and external clients, providing clear and proactive updates.
•Ensure adherence to industry standards and regulatory guidelines regarding data management practices and data quality.
•Address critical data handling and quality assurance issues by implementing necessary corrective actions.


Required Knowledge and Skills:
•Bachelor’s degree in life sciences, statistics, computer science, or a related field, Master’s degree preferred.
•At least 5 years of data management experience in a CRO, pharmaceutical, or biotech environment, with a minimum of 2 years in a leadership capacity.
•Comprehensive knowledge of clinical trial processes and regulatory standards, including GCP, ICH guidelines, and FDA/EMA regulations.
•Proficiency with EDC systems such as Medidata Rave, Medrio, Veeva and familiarity with CDISC standards.
•Expertise in industry-standard data analysis and reporting tools, including SQL.
•Advanced skills in data management software and Microsoft Office Suite.
•Proven ability to manage multiple projects simultaneously while maintaining sharp attention to detail and strong problem-solving skills.
•Strong communication and interpersonal skills, with a track record of promoting collaboration across diverse teams.


Will Be a Plus:
•Programming experience in SAS, JavaScript, or Python is highly advantageous.
•Team leading and mentoring experience.

About P-Product

Founded in 2006, P-product is an international US-based software development company proficient in Web, mobile, desktop & IoT development and support, as well as having extensive expertise in digital signal processors (DSPs), i.e. embedded development.
Our Headquarters are located in Massachusetts while R’n’D centers are in Ukraine: in Kyiv and Kharkiv. We conduct our research and development projects in the Computer Vision, Machine Learning and Artificial Intelligence areas of expertise.

P-Product, Inc. is a growing software consulting company, having high-quality development standards, effective projects expertise and great working experience with customers.

We offer software & hardware development, technical support, IT-consulting, remote administration, and system integration services for various verticals & markets, providing our customers with the best solution for any complex task, creative problem solving and comfortable partnership models.

We have an effective and flexible methodology of works convenient for all our customers. Our Company has good records of accomplishing multi-domain projects for US, European, Asian, and Ukrainian partners.

We started our business from DSP — Digital Signal Processors. We like this word and we want to bring new meaning to the DSP term. We want to be your DSP — your Dedicated Service Provider.

Company website:
http://www.p-product.com/

DOU company page:
https://jobs.dou.ua/companies/p-product/