Senior Manager Systems and Metrics, Clinical Operations

Job Description

Job Description

Who is BlueRock?

BlueRock Therapeutics LP is a clinical stage cell therapy harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases. Two of our novel investigational cell therapies, bemdaneprocel (BRT-DA01) for the treatment of Parkinson’s disease and OpCT-001 for the treatment of primary photoreceptor diseases are clinical stage programs. BlueRock was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves.

What Are We Doing?

Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit.

We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options.

We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients’ lives.

The Senior Manager, Systems and Metrics, will play a critical role in maintaining and refining a data-driven culture within Clinical Operations, under the supervision of the Clinical Operations Leadership.  The role will manage current and future Clinical Operations-owned systems and applications from the business perspective, gather requirements, establish metrics, maintain the lexicon, create processes, support users, oversee data quality, and provide relevant department-level support.  The scope of systems includes but is not limited to operational data dashboards, performance and planning tools, system workflows, communication and collaboration systems, and study documentation systems.  This role requires a proactive, organized, and detail-oriented, professional capable of understanding complex business needs and guiding IT/vendors in the translation of requirements into meaningful solutions in a fast-paced, highly complex environment.

The ideal candidate can demonstrate knowledge of clinical operations business processes, is experienced working with clinical operations data and systems, and can make connections between business and technical needs to create meaningful impact in the biotech and pharmaceutical setting.  Note: This is a business role with a strong working knowledge of technical processes and system design; this is not an IT system manager role.

• Serve as business lead for one or more systems owned by Clinical Operations.  Provide business support for multiple systems and applications used by Clinical operations.
• Work closely with the business owner/lead, IT systems owner/team, and relevant vendor partners.  Contribute to or lead vendor management, where appropriate, dependent on owning department for vendor relationship.
• Work closely with business stakeholders inside and outside of Clinical Operations, where applicable, to understand current processes, needs, gaps, and value potential. Draft business requirements that are clear and actionable by IT/vendor partners.
• Oversee business requirements to successful implementation, including communication to IT/vendor partners and business stakeholders, perform business testing, develop processes/trainings, and where needed, refine requirements.
• Oversee use and accuracy post go-live by monitoring data/metrics, hosting office hours, and managing user inquiries (mailbox).  Utilize a proactive approach to assessing accuracy, troubleshooting, and seeking user feedback.
• Maintain a repository of standard terms, definitions, and calculations utilized in respective systems (the “lexicon”).  Collaborate with stakeholders on business needs, create a common understanding, and build alignment across systems.
• Serve as a system Subject Matter Expert (SME) and provide support to users and teams on various use cases.  This could include providing initial training or guidance ahead of an activity; providing routine support throughout an activity; assisting in vendor management for a subset of data-focused activities or of a vendor-owned system; or, where appropriate, leading the business team on a particular activity e.g., a one-time deep-dive analysis.
• Support department-level system, data or process needs for Clinical Operations.  This will include, but not limited to, management of the department SharePoint page and support on the clinical trials mailbox.
• Support Core Capabilities and broader Clinical Operations team members on system and data-related needs.  This could include SME support for a particular system, compilation of information, or broader input from the system/data/process perspective based on expertise.
• Support/manage process improvement efforts, ensuring adherence to BRT standards, and all applicable regulations and guidelines.
• Review/develop business terms, BRT Working Practices, Standard Operating Procedures (SOPs), templates, training, platforms and systems to drive improvements that are advantageous to BRT.
• Represent values-based leadership consistent with BRT Core Values: courage, urgency, integrity and community.

• Bachelor’s degree and 4-7 years of experience within the pharmaceutical or biotech industry with a focus on systems, data, and/or metrics from a business perspective, or equivalent combination of advanced degree and experience.  Prior formal analytics training and/or education preferred.
• Experience representing the business on technical workstreams or system teams.  Experience working with IT consultants and/or system providers/vendors. 
• Working knowledge of the clinical trial lifecycle, clinical operations responsibilities, cross-functional team member roles, GCP and relevant regulatory guidelines, and clinical operations-relevant systems (e.g. CTMS, EDC, eTMF, Tableau/Spotfire or other data review platforms).  Must have the ability to translate this knowledge into system/data requirements that will have a meaningful business impact.
• Working knowledge of the system development and validation process.
• Demonstrated ability to multi-task and prioritize while working on multiple competing priorities.
• Strong attention to detail, analytical skills, and organizational skills, and with accompanying “big picture” understanding.
• Excellent verbal and written communication skills.
• Ability to work independently and demonstrate accountability.
• Advanced Proficiency in MS Office (Excel, Teams, PowerPoint, Word) and ability to quickly learn new technologies and processes.  Prior experience with Business Intelligence tools (e.g., Tableau, Spotfire, PowerBI) preferred.  Experience leveraging AI in the scope of clinical operations and/or process automation preferred.
• Must be customer focused and able to manage challenging priorities and remain flexible and adaptable in stressful situations.
• Willing to travel up to 15% of the time.

Salary Range: $154,000 - $180,000 

#LI-AL1

BlueRock Therapeutics Company Culture Highlights

Winner of Boston Business Journal's Best Places to Work (Mid-size Company) 2023

Winner of Comparably's Award for Best Company for Diversity 2022

Winner of Comparably's Award for Best Company for Women 2022

Winner of Comparably's Award for Best CEO 2022

BlueRock Therapeutics is ranked in the top 5% of companies for Overall Culture on Comparably.

Engineering Department is ranked in the top 5% of companies for Overall Culture on Comparably.

Check us out on Comparably: -therapeutics

Follow us on Linkedin:

Equal Opportunity Workplace:   At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace.  Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.