{"id":3953651,"url":"https://alion.io/job/direct-biologics-director-data-management","title":"Director, Data Management","company":{"id":4474737,"name":"Direct Biologics","domain":"directbiologics.com","url":"https://alion.io/company/direct-biologics","size_band":"11-50","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workable","truth_index":null},"role":"Leadership","role_family":"Leadership","seniority":"head","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Austin, United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"GCP","optional":false},{"name":"GMP","optional":false},{"name":"Good Clinical Practice","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-09-22T00:00:00Z","employer_posted_date":"2026-09-22","last_verified_at":"2026-11-10T06:00:06Z","board_verified":true,"closed_at":null,"days_open":49,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":49},"description":"Direct Biologics is a science-based market leading innovator and certified cGMP manufacturer of regenerative biologic products driven by science and innovation. Our company is dedicated to delivering cutting-edge clinical and scientific solutions through meticulous research efforts. Direct Biologics prioritizes patient safety above all else. All regulated processes adhere to cGxP standards, guaranteeing the utmost safety and quality at every phase of product development. Direct Biologics delivers high-quality products for healthcare providers and patients alike. Our commitment to excellence is upheld through our quality systems, ensuring the consistent provision of safe products. Direct Biologics was established with the goal of advancing the frontier of cutting-edge human cell and tissue technologies. Our company has amassed substantial intellectual property focused on stem cell secretomes and their applications.\nRequirements\nSome required skills for the Scientist position:\nStrong knowledge of FDA regulations and ICH-GCP guidelines\nThorough knowledge of the clinical research process\nStrong interpersonal skills with the ability to effectively communicate cross-functionally at all levels of the organization, as well as externally with stakeholders and ESPs\nAbility to identify issues and independently assess and recommend specific solutions\nStrong organizational skills, prioritization, time management, and cross functional collaboration \nPrimary Roles and Responsibilities:\n Successful and timely execution of DM activities and deliverables in compliance with International Council for Harmonisation (ICH)/Good Clinical Practice (GCP) guidelines and Standard Operating Procedures (SOPs)\nDevelops and/or approves DM documents (e.g., Data Management Plan, Data Transfer Agreements, Data Review Plans, etc.)\nDesigns and develops Electronic Data Capture (EDC)\nOversees and coordinates EDC integrations\nDevelops and maintains standard Case Report Form library\nProvides subject matter expertise to the development of other trial documents (e.g., Protocols, Monitoring Plans, Statistical Analysis Plans, Clinical Study Reports, etc.)\nProactively identifies, mitigates, and manages risk in data management issues.\nDevelops and implements DM SOPs in partnership with Clinical Operations and Quality Assurance\nManages DM external service providers (ESPs)\nRepresents DM in interactions with regulatory authorities, as needed\nApplies current industry best practices to DM systems and processes\nLeads, trains and mentors DM personnel\nPerforms other duties as assigned\nQualifications:\nBA/BS in life sciences relevant field, preferable.\n10+ years of relevant industry experience\nExperience managing department personnel\nExperience with relevant EDC systems\nProficiency in Microsoft Office 365\nBenefits\n Health Care Plan (Medical, Dental & Vision)\n Company 401k match up to 4%\n Paid Time Off (Vacation & Sick) \n Holidays\n Stock Option","description_format":"text","description_chars":2940,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["401k plan"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":[],"lifecycle":[{"event":"open","at":"2026-11-09T06:18:14Z"}],"visa":[],"liveness":{"score":15,"band":"cold","label":"Long shot","p_open":1,"p_active":0.441,"p_room":0.35,"age_days":49,"expected_fill_days":7,"reasons":["conf:0","win:tail"],"computed_at":"2026-11-10T06:52:35Z"},"pay":null,"html_url":"https://alion.io/job/direct-biologics-director-data-management","json_url":"https://alion.io/job/direct-biologics-director-data-management.json","meta":{"generated_at":"2026-11-10T11:39:39Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":27077,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-11T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":4474737},"rest":"https://alion.io/mcp/rest/get_company?id=4474737"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fdirect-biologics-director-data-management"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fdirect-biologics-director-data-management"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fdirect-biologics-director-data-management"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/direct-biologics-director-data-management\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fdirect-biologics-director-data-management"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3953651}},{"tool":"search_jobs","arguments":{"company":"directbiologics.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3953651},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. Docs: https://alion.io/developers"}}