Compliance Manager- Digital Health / Clinical Trials / Research Data
OpenClinica LLC Waltham, MA
- Expired: over a month ago. Applications are no longer accepted.
As a Compliance Manager, you’ll work with the CEO to ensure that OpenClinica is conducting its business in full compliance with applicable life science, healthcare, information security, and data privacy laws and regulations, as well as professional standards, accepted business practices, and internal requirements.
You will maintain OpenClinica’s Quality System and Information Security Program, adhering to the frameworks of ICH Good Clinical Practice, 21 CFR Part 11, HIPAA, and GDPR. You will also work to achieve full compliance with SOC 2 and ISO 27001 Certification Requirements.
On any Given Day you might:
- Assist or lead in the development, maintenance, and revision of SOPs, policies, procedures, work instructions, and other materials related to OpenClinica’s quality system and information security program
- Support customer audits and questionnaires in a timely, rigorous manner
- Lead pursuit of ISO 27001 and SOC 2 certification
- Partner with colleagues (Executive team, IT, Engineering, HR, Finance, etc.) to identify, develop and communicate new/updated policies and spread general awareness about policy set
- Ensure policies and procedures are adhered to and meet the needs and goals of the company
- Gather and store artifacts to demonstrate adherence
- Partner with internal teams to test compliance with our policies
- Lead training for employees and contractors on OpenClinica’s quality system and information security program
- Maintain systems that support the responsibilities above (online training, document management)
- Stay abreast of legal, security, and regulatory changes that could impact our program
- Other duties as deemed necessary to ensure successful outcomes.
- 2+ years’ experience in Compliance, GxP, IT, Information Security, Legal, Data Privacy or a related industry
- Highly detail oriented
- Experience and/or interest in IT and/or Information Security
- Excellent writing skills, with experience as a writer or technical editor a plus
- Customer service mindset
- Strong organization and time management skills
- Ability to converse comfortably with varied audiences (based on skillset, experience, business and technical teams, executive level, etc)
- Ability to take direction and independently work through projects as required
- FDA / GxP / Part 11 experience a major plus
- Bachelor’s Degree, preferably in IT, Information Security, Risk Management, Law, or Data Privacy
This position is considered US-Remote.
Benefits & Culture:
Compensation is competitive and includes base salary + bonus.
We don’t just offer your traditional benefits like:
- 401k plan with matching
- Flexible Spending Accounts
- Health, dental & vision insurance
- Life insurance
- Leave of Absences
- Flexible paid time off
We also offer some useful and fun perks, such as:
- A professional development budget just for you!
- Free parking to keep you sane
- Free gym to keep you healthy
- Free snacks to keep you nourished
- A fun, collaborative culture!
OpenClinica LLCWhy Work Here?
We’re transforming research by delivering cloud applications that make it easier to run clinical trials. And having fun doing it!
OpenClinica accelerates the pace of healthcare innovation by working to automate the clinical research process. We have a rapidly growing customer base, and while we’re a small company, we are already a globally recognized brand in clinical research. We offer valuable experience and opportunities for leadership that are hard to find elsewhere, as well as the opportunity to contribute towards accelerating COVID research.
1075 Main StWaltham, MA
HealthcareView all jobs at OpenClinica LLC