Compliance Specialist – Patient-Centered Outcomes

We are recruiting a Compliance Specialist to join our team in Boston, MA and the role can be a hybrid of in-office and remote working. Our work involves conducting healthcare research with patients, parents/caregivers, and healthcare professionals. We work with partner recruitment agencies and fieldwork agencies in countries around Europe and the US to identify and interview these research participants, and with suppliers to perform transcription and translation of interview transcripts and questionnaires, and other external companies to create electronic versions of questionnaires. This involves the handling of personal data associated with the research conducted by our project teams.

To ensure our ongoing compliance with relevant regulations, standards, and policies, we are looking to expand our global compliance team. The ideal candidate will have knowledge of quality standards activities and data protection requirements, preferably within the pharmaceutical industry and/or a research consultancy environment, and some level of general experience in supplier management is a plus. Knowledge and awareness of GDPR and its implications for research and businesses involved in handling personal data is desirable as well as knowledge of US Privacy regulations and HIPPA. Training will be provided; however, a drive to learn the full scope of skills required for this role is essential. A genuine interest in establishing and providing guidance to project teams in following standard procedures will be important. Fluency in the use of Microsoft Word, Excel, and PowerPoint, a good standard of written and spoken English and basic arithmetic, strong organizational skills, self-starting, and very close attention to detail are essential, along with a team working ethos and an appetite for working in a fast-paced and collaborative environment.

This position is a fantastic growth opportunity for someone with experience in the development and implementation of Standard Operational Procedures (SOPs), information governance, and background knowledge of GDPR as well as exposure to supplier management and/or operations. As a member of the global compliance team, you will be involved in activities to identify and implement standards, systems, procedures, and working practices to ensure maximum quality, compliance, and efficiency across the team. In this role, you will ensure standards and policies for the management of information relating to data subjects are in place and followed across all research activities while ensuring consistency in standards across Adelphi Values’ global teams. This will involve reviewing and updating compliance policies, procedures, and training materials, delivering select trainings, and tracking the completion of required staff trainings. You will pro-actively partner with our teams to provide hands-on guidance and support at a project level. You will prepare for and participate in internal and external client audits and assume responsibility for assigned actions following the audits with support from the broader compliance team. You will also assist in the qualification of new suppliers and guide them in their completion of the company supplier assessment.