June 9, 2026
Activation Manager
Senior • Remote
120 - 140 PLN
Bialystok, Poland
The Activation Manager is the primary guardian of the end-to-end data product lifecycle within the DSO, overseeing the journey from initial intake to final certification. Acting as the first point of entry for data product teams, you will manage risk assessments, ensure rigorous classification, and validate that all necessary controls are effectively met.
Key Responsibilities
Pipeline Orchestration: Manage the full intake-to-certification workflow, ensuring every data product moves through the necessary security and compliance milestones.
Risk & Classification: Apply standardized risk-tiering methodologies to categorize data products, identifying specific triggers for specialist reviews (e.g., AI, cross-border, or commercialization).
Pattern Governance: Maintain and update the DSO pattern library, ensuring that classification artifacts are consistent and drive accurate control implementation.
Certification & Validation: Conduct post-implementation reviews of evidence (attestations, documentation) to determine if control requirements have been satisfied, providing final certification decisions based on established procedures.
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Stakeholder Liaison: Serve as the strategic technical and procedural advisor for data product teams, bridging the gap between engineering and risk management.
Core Competencies
Methodological Rigor & Analysis
Framework Adherence: Ability to execute tasks within a structured methodology consistently. You recognize when a project follows a standard pattern and possess the judgment to escalate outliers to the IDE Lead.
Pattern Recognition: A sharp eye for "red flag" triggers—such as client data usage or AI integration—within complex intake documentation.
Communication & Documentation
Analytical Writing: Capacity to translate technical classification logic into clear, non-jargon narratives. Every conclusion must be traceable and understandable to stakeholders outside the DSO.
Evidence Appraisal: Skilled in evaluating documentation against strict criteria. You don't just reject incomplete evidence; you provide constructive feedback on what is missing to reach compliance.
Relationship Management
Multi-level Coordination: Comfortable navigating a wide range of stakeholders, from senior executive sponsors to software engineers. You know how to balance diplomacy with the need for technical clarity.
Consultative Posture: Focused on providing a "path to yes"—helping teams move faster with confidence rather than simply enforcing barriers.
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🏢 Summary: Leadership role overseeing clinical data management across development programs, ensuring high-quality, compliant clinical trial data from study start-up through database lock and regulatory submission. The position drives data strategy, database design, vendor oversight, PK data review, and cross-functional collaboration to support successful clinical and regulatory outcomes. Strong focus on regulatory compliance, inspection readiness, and industry data standards. 🗂️ Requirements: BS/BA in bioscience, engineering, computer science, medical or related field, 6+ years (MS) or 9+ years (BS) clinical data management experience for Senior Manager, 9+ years (MS) or 12+ years (BS) clinical data management experience for Associate Director, Experience leading data management from study start-up through database lock, Strong vendor and CRO oversight experience, Experience supporting regulatory submissions and inspection readiness, Knowledge of ICH-GCP and FDA regulations, Experience with EDC systems (e.g., Medidata Rave) 📃 Skills: EDC, Medidata, Rave, CDISC, CDASH, SDTM, MedDRA, WHODrug, ICH-GCP, FDA, 21CFRPart11, PK, UAT, SOP, GCDMP 🏢 Description: Position Summary: Senior Manager / Associate Director, Clinical Data Management to provide leadership and oversight of clinical data management activities across one or more development programs. This individual is responsible for ensuring the quality, integrity, timeliness, and regulatory compliance of clinical trial data from study start-up through database lock and submission readiness. Working closely with Clinical Operations, Clinical Development, Biostatistics, Statistical Programming, Clinical Pharmacology, Pharmacovigilance, Regulatory Affairs, Information Technology, and external partners, this role serves as the Data Management lead for assigned studies and programs, driving data strategy, vendor oversight, process excellence, and inspection readiness. Essential Duties and Responsibilities: Clinical Data Management Leadership - Lead clinical data management activities for assigned studies (especially PK trials) from protocol development through database lock and submission readiness. - Serve as primary point of contact for CROs and vendors, ensuring data delivery on time, within budget, and in compliance with ICH-GCP guidelines. - Represent Data Management on cross-functional study teams, aligning deliverables with study objectives, timelines, and regulatory requirements. - Develop and execute study-specific data management strategies to ensure high-quality, analyzable clinical trial data. - Oversee and maintain Data Management Plans (DMPs), data review plans, and study-level documentation. Database Design, Build, and Validation - Collaborate on design and review of electronic Case Report Forms (eCRFs). - Develop and review database build specifications, edit check specifications, CRF completion guidelines, and validation plans. - Lead User Acceptance Testing (UAT) and oversee database go-live readiness. - Ensure databases are designed and validated in accordance with protocol requirements, CDASH standards, and best practices. Data Review and Quality Oversight - Lead ongoing PK and clinical data review, discrepancy management, query generation, and resolution. - Establish and monitor data quality metrics to ensure accuracy, consistency, completeness, and analysis readiness. - Oversee reconciliation activities including SAEs, laboratory data, medical coding, protocol deviations, and external data sources. - Manage MedDRA and WHODrug coding activities. - Support database lock activities and final data transfers for statistical analysis and regulatory submissions. Vendor and CRO Management - Manage bioanalytical vendors for PK assays and ensure appropriate data collection. - Provide oversight of CROs, EDC providers, specialty laboratories, and other external vendors. - Participate in vendor selection, RFP reviews, and vendor assessments. - Review vendor contracts, data transfer agreements, and service deliverables. - Monitor vendor performance, timelines, quality metrics, and issue resolution. Cross-Functional Collaboration - Partner with Biostatistics and Statistical Programming to support data review, SAP development, listings review, and submission readiness. - Collaborate with Clinical Operations, Clinical Pharmacology, Safety, Regulatory Affairs, and Medical teams to ensure accurate data collection and reporting. - Provide data management updates, risk assessments, and recommendations in study team meetings. - Support preparation and review of clinical study reports, tables, listings, and regulatory submission deliverables. Process Improvement and Compliance - Contribute to development and continuous improvement of Data Management processes, SOPs, standards, and best practices. - Ensure compliance with ICH-GCP, FDA regulations, CDISC/CDASH standards, GCDMP guidelines, and company procedures. - Support inspection readiness and participate in regulatory inspections and audits. - Mentor junior team members and contribute to team development. Required Education and Experience: - BS/BA in bioscience, engineering, computer science, medical training, or related field; MS/MA preferred. - Senior Manager: 6+ years (MS/MA) or 9+ years (BS/BA) of clinical data management experience in biotechnology, pharmaceutical, or CRO industry. - Associate Director: 9+ years (MS/MA) or 12+ years (BS/BA) of clinical data management experience in biotechnology, pharmaceutical, or CRO industry. - Experience leading data management from study start-up through database lock. - Strong vendor and CRO oversight experience. - Experience supporting regulatory submissions and inspection readiness. Preferred: - Management of PK trial data and clinical pharmacology experience. Additional Skills, Knowledge, and Abilities: - Deep understanding of clinical data management principles and industry standards. - Working knowledge of ICH-GCP, FDA regulations, 21 CFR Part 11, CDISC/CDASH, SDTM, MedDRA, and WHODrug. - Experience with EDC systems such as Medidata Rave or equivalent. - Experience with drug development and PK sample collection. - Strong understanding of external data integrations, reconciliation processes, and database lock procedures. - Strong project management, organizational, and problem-solving skills. - Ability to manage multiple priorities in a fast-paced environment.
Technology

Empower Pharmacy
Manager, Sales Development
Senior
On-site
Houston, TX
🏢 Summary: Leadership role responsible for driving inbound sales pipeline growth, market expansion, and revenue acceleration within a highly regulated pharmacy environment. The position leads sales development strategy, team performance, AI-driven analytics adoption, and cross-functional collaboration to optimize forecasting, prospecting, and operational execution. Focused on scalable processes, compliance, and data-driven decision-making to achieve aggressive commercial targets. 🗂️ Requirements: Bachelor's degree in Business, Marketing, Communications, Healthcare Administration or related field, Minimum 5 years experience in sales development, business development, inside sales, or commercial operations, Minimum 3 years direct people leadership experience, Experience with CRM platforms and sales engagement technologies, Experience using AI-enabled analytics and business tools, Strong knowledge of inbound sales methodologies and pipeline management, Experience in regulated, fast-paced environments, Valid driver's license 📃 Skills: CRM, AI, Analytics, Forecasting, Automation, Reporting, Segmentation, LeadScoring, Dashboards, Workflow, SalesEngagement 🏢 Description: POSITION SUMMARY The Manager, Sales Development drives pipeline generation, market expansion, and revenue acceleration by leading a high-performing inbound sales organization within a hyper-growth, highly regulated 503A and 503B pharmacy environment. This role owns sales development strategy, prospecting execution, talent performance, forecasting accuracy, and cross-functional alignment across commercial operations, marketing, analytics, and customer engagement initiatives. The leader leverages AI as a force multiplier to increase speed, scale, lead quality, workflow efficiency, and data-driven decision-making while strengthening operational rigor and customer acquisition outcomes. RESPONSIBILITIES Sales Leadership Pipeline Ownership: Lead and optimize the sales development function by establishing scalable inbound strategies, driving qualified pipeline growth, and aligning prospecting priorities with enterprise revenue objectives. Utilize AI-enabled analytics, workflow automation, and performance intelligence tools to improve targeting precision, accelerate conversion velocity, and enhance forecasting accuracy. Coach high-performing teams through structured accountability, measurable execution standards, and continuous development practices. Talent Development: Recruit, develop, and retain high-performing sales development talent within a fast-paced, highly regulated healthcare environment. Implement structured onboarding, coaching frameworks, and performance management processes. Leverage AI-driven coaching insights, conversation intelligence, and productivity analytics to personalize development plans and accelerate performance outcomes. Performance Execution: Drive operational excellence through disciplined management of sales activity metrics, pipeline health, prospect engagement, and conversion performance. Establish rigorous performance expectations and implement corrective actions to improve efficiency and accountability. Utilize AI-powered dashboards, predictive insights, and reporting tools to strengthen decision-making and optimize resource allocation. Market Expansion Prospecting Strategy: Design and execute targeted inbound prospecting initiatives that expand market reach and accelerate customer acquisition. Partner with marketing, sales leadership, and commercial operations to align outreach strategies with business priorities. Utilize AI-enabled segmentation, lead scoring, and behavioral insights to improve prospect quality and engagement strategies. Customer Engagement: Establish consistent communication standards and data-informed outreach strategies aligned with growth objectives. Collaborate cross-functionally to ensure seamless customer experiences while maintaining regulatory compliance. Leverage AI-supported engagement tools and automation platforms to increase responsiveness and improve conversion effectiveness. Growth Alignment: Align sales development initiatives with enterprise growth strategy by translating priorities into measurable execution plans and operational targets. Apply AI-enabled forecasting, trend analysis, and performance monitoring tools to identify opportunities and accelerate growth initiatives. Operational Excellence Process Optimization: Improve sales development processes and workflows to support scalability and execution rigor. Establish performance benchmarks and implement solutions that enhance productivity and customer acquisition outcomes. Utilize AI-driven automation and reporting capabilities to streamline activities and improve data accuracy. Data Governance: Ensure integrity and accuracy across sales development data and reporting systems. Partner with commercial operations and analytics teams to standardize measurement practices and improve business intelligence. Leverage AI-powered analytics platforms to identify trends and optimize pipeline management. Compliance Management: Maintain adherence to organizational policies and regulatory requirements within a highly regulated environment. Reinforce accountability and ethical conduct across all sales development activities. Utilize AI-enabled monitoring tools and workflow controls to strengthen compliance visibility and reduce operational risk. Cross-Functional Collaboration Strategic Partnership: Build collaborative partnerships across sales, marketing, analytics, customer engagement, and operational teams to support scalable growth. Utilize AI-supported collaboration platforms and reporting tools to improve transparency and execution. Business Communication: Deliver clear communication to executive leadership and stakeholders regarding performance results and strategic priorities. Translate complex data into actionable business insights using AI-driven reporting and visualization tools. Innovation Leadership: Identify emerging technologies and process enhancements to strengthen sales development effectiveness. Encourage continuous learning and data-driven experimentation while maintaining operational discipline within a regulated environment. KNOWLEDGE AND SKILLS - Expertise leading sales development organizations and inbound prospecting strategies - Proficiency with CRM platforms, sales engagement technologies, AI-enabled analytics tools, forecasting systems, workflow automation, and reporting tools - Strong communication, coaching, and stakeholder management skills - Ability to optimize business processes and implement scalable solutions in regulated environments EXPERIENCE AND QUALIFICATIONS - Bachelor's degree in Business, Marketing, Communications, Healthcare Administration, or related field required; Master's preferred - Minimum 5 years of progressive experience in sales development, business development, inside sales, or commercial operations leadership - Minimum 3 years of direct people leadership experience - Experience utilizing CRM platforms, sales engagement technologies, analytics tools, and AI-enabled business solutions - Strong understanding of inbound sales methodologies, prospecting strategies, and pipeline management - Experience operating within highly regulated, fast-paced environments - Valid driver's license required - Preferred certifications: CSP, CBDP, SSLC or related credentials Employee Benefits, Health and Wellness: Comprehensive benefits including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, IV therapy, and compounded medications. Physical Requirements: Role requires frequent communication, prolonged stationary work, regular computer use, movement around the office and campus, and physical activities such as standing, walking, reaching, climbing, balancing, stooping, kneeling, crouching, or crawling.
Technology

Peak Energy
Automation Manager
Senior
On-site
Sacramento, CA
159,996 - 185,004 USD/yr
🏢 Summary: Leadership role responsible for building and managing the automation and controls infrastructure of a new 24/7 sodium-ion battery manufacturing facility. The position combines hands-on PLC and SCADA technical expertise with team development, equipment commissioning, and control system architecture ownership. The Automation Manager will define standards, lead FAT/SAT processes, integrate PLCs with MES, and ensure high system uptime and safety compliance. 🗂️ Requirements: Minimum 5 years managing Controls Engineers in industrial manufacturing, Hands-on experience with Beckhoff PLCs and TwinCAT v3, Experience integrating PLC/SCADA systems with MES platforms, Participation in equipment design reviews and Factory Acceptance Tests (FATs), Proficiency in SCADA systems, HMI design, industrial data acquisition, Ability to define and document 24/7 operational procedures, BS or MS in Electrical Engineering, Control Systems Engineering, or related field (or equivalent experience), Willingness to travel internationally up to 25% 📃 Skills: Beckhoff, TwinCAT, PLC, SCADA, MES, HMI, Ignition, AI, ElectricalEngineering, ControlSystems 🏢 Description: Role: Automation Manager Department: Manufacturing Reports To: Head of Automation About the Role: Automation Manager The Automation Manager is responsible for building and leading the automation and controls infrastructure that keeps Peak Energy's sodium-ion battery manufacturing facility running at full capacity, 24 hours a day, 7 days a week, across a 4-shift operation. This role is both strategic and deeply technical: you'll have direct input into the architecture of our control systems, hire and develop a team of Controls Engineers and Technicians, participate in the acquisition and commissioning of new industrial manufacturing equipment, and create the operational procedures that ensure rapid, reliable response when systems need attention. Our Sacramento manufacturing facility is in the planning and build-out phase. This person will be hired to help open it. That means participating in equipment design reviews and international Factory Acceptance Tests as manufacturing equipment is selected and commissioned, and building the controls team, procedures, and documentation standards the facility will run on from day one. There is no existing playbook to inherit; this person will write it. This role requires someone who is comfortable operating at both the technical and organizational level: debugging a control system issue and then writing the procedure that prevents the next one. What You'll Do - Lead the controls and automation function for the manufacturing facility, maintaining system uptime across a 24/7, 4-shift production schedule - Participate in design reviews for the acquisition of industrial manufacturing equipment, providing input on automation architecture, PLC platform compatibility, and control system specifications - Lead and participate in international Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs) for newly acquired industrial manufacturing equipment - Build, hire, and develop a team of Controls Engineers and Controls Technicians (7–12 team members) - Define and own shift coverage models, escalation protocols, and response procedures; create documentation governing automation issue response - Establish and maintain PLC architecture standards across the facility, with Beckhoff TwinCAT as the primary platform - Design and implement connectivity between PLCs and MES systems to enable real-time production data, traceability, and process monitoring - Create, maintain, and continuously improve automation documentation: control system designs, change management procedures, operator manuals, and maintenance protocols - Collaborate with equipment engineers, process engineers, and manufacturing leadership to align automation systems with production goals - Own controls and automation KPIs: system uptime, mean time to repair (MTTR), alarm rationalization, and preventive maintenance compliance - Establish and enforce safety standards for control systems, including emergency shutdown procedures and safety interlocks - Drive continuous improvement in automation to reduce manual intervention, improve yield, and increase throughput What You'll Bring - Minimum 5 years of experience managing Controls Engineers in an industrial manufacturing environment - Hands-on technical experience with Beckhoff PLCs and TwinCAT v3 - Experience establishing connectivity between PLC/SCADA systems and MES platforms - Experience participating in equipment design reviews and Factory Acceptance Tests (FATs) - Proficiency with SCADA systems, HMI design, and industrial data acquisition platforms - Ability to define and document operational procedures for 24/7 teams - BS or MS in Electrical Engineering, Control Systems Engineering, or related discipline, or equivalent experience - Strong organizational and communication skills - Comfort with scheduling and coordination in continuous manufacturing operations - Willingness to travel internationally (up to 25%) Preferred Qualifications - Experience in battery manufacturing, semiconductor manufacturing, or high-precision industrial environments - Familiarity with Ignition by Inductive Automation for SCADA and data acquisition - Experience scaling from pilot production to commercial-scale manufacturing - Familiarity with energy storage system architecture and battery manufacturing processes - Comfort using modern AI tools in daily workflow Compensation and Benefits - Salary range: $160,000 - $185,000 - Flexible time off - Comprehensive medical, dental, and vision coverage - Strong 401(k) plan - Equity opportunities - Additional work perks Equal Employment Opportunity The company is an equal opportunity employer and does not discriminate on the basis of legally protected status.