Title: Associate Director, TMF Operations Location: Needham, MA Job Description: Full Time Manager/Supervisor Salary: $184-$210k + bonus + options + benefits Hybrid role- 2-3 days in Needham office Why Work With Us? At Candel, our people drive our success. We value diversity, collaboration, and bold thinking in a supportive, mission-driven environment. Like a team, we show up for each other and stay focused on making a difference for patients and families. Our leadership is transparent and empowering, and our culture is built on trust, flexibility, and accountability, encouraging ownership and innovation every day. Our Science: Advancing Cancer Immunotherapies Candel is a clinical-stage biopharma company developing off-the-shelf, multimodal immunotherapies that stimulate personalized, systemic anti-tumor responses. Our platforms use genetically modified adenovirus and HSV constructs. With positive Phase 3 results for our lead candidate, it’s an exciting time to join us and help bring transformative cancer treatments to patients. Learn more: www.candeltx.com Position Summary: We’re looking for an experienced Associate Director, Trial Master File (TMF) Operations to lead the Trial Master File operations across our oncology clinical programs. This role is ideal for someone who enjoys creating structure in a fast-paced biotech environment and can confidently partner across Clinical Operations, Quality, Regulatory, IT, and external vendors to ensure inspection readiness and operational excellence. You’ll play a critical role in strengthening TMF strategy, oversight, quality, and reporting infrastructure while helping build scalable processes that support a growing clinical portfolio. This is a highly visible opportunity for someone who combines strategic thinking with hands-on execution and enjoys driving continuous improvement. What You’ll Do: • Lead TMF operational strategy and help build scalable, inspection-ready processes across ongoing and future clinical studies • Drive oversight of electronic TMF activities to ensure quality, completeness, accuracy, and regulatory compliance across internal teams and external partners • Develop and refine TMF standards, governance models, workflows, and procedural documentation aligned with industry best practices and global regulations • Act as a trusted TMF subject matter expert and strategic partner to Clinical Operations leadership and cross-functional stakeholders - Management of the eTMF system vendor • Establish and monitor TMF health metrics, dashboards, and operational KPIs to identify trends, risks, and opportunities for improvement • Conduct TMF reviews, quality assessments, and operational audits to ensure inspection readiness at all times • For outsourced studies, partner closely with CROs and vendors to ensure deliverables, timelines, expectations, and performance standards are consistently met • Support implementation, optimization, and integration of TMF-related systems and technologies including eTMF platforms, CTMS, EDC, and other clinical systems • Collaborate with IT and business stakeholders on system enhancements, upgrades, validation activities, and change management initiatives • Help drive operational excellence by identifying process gaps, improving workflows, and creating sustainable solutions that support organizational growth • Provide training and guidance to internal teams on TMF processes, expectations, and best practices • Support clinical trial disclosure and registry compliance activities in partnership with cross-functional teams What You Bring: • Bachelor’s degree in a scientific, healthcare, or related discipline, or equivalent industry experience • 10+ years of clinical research experience within biotech, pharmaceutical, or CRO environments • Strong background in TMF operations, document management, and inspection readiness activities • Hands-on experience managing eTMF systems and TMF reporting processes • Deep understanding of ICH-GCP requirements, TMF best practices, and global regulatory expectations • Experience working collaboratively with CROs, vendors, and cross-functional stakeholders in a matrixed environment • Ability to operate effectively in a growing biotech company where priorities may evolve quickly • Strong organizational skills with the ability to manage multiple priorities while maintaining exceptional attention to detail • Excellent communication, collaboration, and problem-solving skills • A proactive mindset with the ability to work independently, influence others, and drive initiatives forward Work Environment: • Hybrid role based in Needham, MA • Regular onsite collaboration expected approximately 2–3 days per week depending on business needs • Occasional travel may be required to support audits, inspections, vendors, or cross-functional meetings You must be authorized to work in US. We are unable to provide any sponsorship at this time. NOTE: We are not allowing agencies at this time.

• Own the implementation and ongoing refinement of Karoo Health care model • Translate evidence-based cardiology guidelines into practical and scalable care protocols • Test, iterate, and standardize care protocols to meet the needs of individual markets and payer arrangements • Ensure the Karoo Health care model supports value-based care • Operationalize the clinical model across care teams, developing SOPs, staffing models, role definitions, and training materials • Identify operational bottlenecks or clinical variation and drive continuous improvement initiatives • Support market launches by ensuring clinical readiness, workflows, and staffing are in place • Provide operational support to Karoo’s clinical team (RNs, LCSW, MAs, etc.) • Support hiring, onboarding, training, and performance management of clinical staff • Foster a culture of patient-centered, data-informed, high-quality care delivery • Partner with Analytics and Finance to define and monitor clinical KPIs tied to value-based contracts • Use data to assess clinical effectiveness and identify opportunities to improve outcomes and reduce avoidable utilization • Collaborate with partner cardiology practices to ensure smooth integration of Karoo’s clinical model into existing workflows • Ensure clinical operations meet regulatory, licensure, and quality standards across states and care settings • Work closely with Product to inform clinical requirements for tools, workflows, and dashboards • Partner with Market Ops, and Growth teams to align clinical delivery with expansion goals

Role Description The Clinical Operations Manager (COM) for Peripheral Nerve Stimulation Therapy is responsible for leading a national team of Field Clinical Managers to drive clinical excellence, patient support, and sales enablement for the PNS Therapy product portfolio. This role blends clinical leadership with operations management, field service operations, and customer engagement, ensuring optimal patient outcomes while maximizing operational efficiency and customer satisfaction. - Hire, coach, and develop a national team of Field Clinical Managers - Implement engagement, retention, and development plans to ensure a highly motivated team, reduced turnover, and continuous employee growth - Conduct regular field observations (case coverage, ride-alongs, OR/clinic support) - Drive a culture of accountability, customer focus, continuous improvement, and operational discipline - Collaborate with sales leadership to develop and execute account strategies, including new customer onboarding and growth initiatives - Ensure delivery of high-quality clinical support for PNS procedures, including adherence to protocols, regulatory requirements, and patient safety standards - Build systems and processes that enable efficient clinical coverage and operational consistency - Ensure timely and efficient case coverage through optimized clinician deployment and capacity planning based on current and future-state business needs - Oversee workload balancing, staffing models, and territory alignment to maximize utilization and minimize inefficiencies - Establish and enforce clinical competency frameworks, training programs, and certification processes - Participate in customer education events, cadaver labs, and workshops - Ensure adherence to regulations, policies, and code of ethics Qualifications - Bachelor’s degree required; advanced degree preferred - 7+ years of experience in medical devices, including field clinical roles - 2+ years leading a field-based team in service delivery or clinical support - Implantable, wearable, or programmable medical device experience preferred - Experience in surgical/procedural and OR-based environments - Demonstrated success in clinical operations and continuous improvement - Strong coaching and performance management skills - High emotional intelligence and adaptability in clinical environments - Excellent communication with physicians and executive stakeholders - Strong cross-functional collaboration skills Requirements - This is a remote position requiring 50% or more travel - Proximity to a major airport in the Eastern or Central time zone is a plus Company Description Bioventus is committed to fostering an inclusive and diverse community of employees with a strong sense of belonging. We believe we are bettered by all forms of diversity and take pride in working with top talent from every walk of life. In the spirit of inclusivity, qualified applicants will be considered without regard to age, ethnicity, disability, gender, veteran status, gender expression, gender identity, nationality, race, religion or sexual orientation. All individuals, regardless of personal characteristics, are encouraged to apply.

Role Description This job is based remotely in the US, but you should be based in an Eastern or Central Time zone. At CoMind, we are developing a non-invasive neuromonitoring technology that will result in a new era of clinical brain monitoring. In joining us, you will be helping to create cutting-edge technologies that will improve how we diagnose and treat brain disorders, ultimately improving and saving the lives of patients across the world. The Clinical Team leads the deployment of CoMind's technology into hospital environments for the first time, managing clinical sites, supporting device installations, and ensuring the smooth execution of clinical studies in partnership with clinicians. As Clinical Project Manager, you will own the planning, execution, and oversight of assigned clinical studies, working cross-functionally with clinical operations, regulatory, data science, and investigator sites to ensure studies are delivered on time, within budget, and in full compliance with applicable regulations. Please note that this role will require approximately 20% travel, depending on study needs. - Develop and maintain clinical project plans, timelines, and budgets; lead site feasibility assessments, selection, and CTA negotiations for assigned studies - Prepare and review key study documents including protocols, ICFs, CRFs, and study manuals in accordance with ISO 14155, FDA/ICH guidelines, and CoMind SOPs - Oversee site initiation, monitoring, and close-out visits, ensuring protocol adherence and data quality; track enrollment and KPIs and proactively mitigate risks to study timelines - Review monitoring reports and drive timely resolution of site issues, deviations, and CAPA activities - Manage clinical data activities including CRF completion, query resolution, and data cleaning in collaboration with data management - Ensure study conduct compliance with 21 CFR Parts 812, 50/56, ISO 14155, and GCP; support internal and external audits and FDA inspections as required - Author and review clinical study reports, periodic safety reports, and clinical evaluation reports; provide regular study status updates to senior management and cross-functional stakeholders AI is fundamental to our culture -- it's not just a tool, but a core part of how we work, collaborate, and innovate. We expect all team members to embrace AI in their daily work and continuously find new ways to use it effectively. Qualifications - 3-6 years of clinical research experience, with at least 2 years in medical device clinical trials - Demonstrated knowledge of FDA regulations (21 CFR 812), ISO 14155, and GCP guidelines - Hands-on experience managing clinical sites and/or CRO relationships - Proficiency with EDC, eTMF, CTMS, and standard office software - Strong communication, organisational, and documentation skills with the ability to manage multiple studies simultaneously Nice to have - Familiarity with neurology, neurocritical care, TBI, or ICU-based clinical settings - Experience authoring or contributing to clinical study reports or clinical evaluation reports Benefits - Company equity plan - Annual Unlimited PTO - Health insurance plan - CoMind contributes 50% to the monthly premium (with the Blue Cross Network) - Dental insurance (50% Employer Contributions to individual policy) - Vision insurance (50% Employer Contributions to individual policy) - 401k plan with an employer match up to 3% - Mental health resources