Staff Scientist, Clinical Research

Job not on LinkedIn

🔥 15 hours ago

⛰️ Colorado, Pennsylvania – Remote

⛰️ Colorado – Remote 🔔 Pennsylvania – Remote

💵 $109k - $174.8k / year

⏰ Full Time

🔴 Lead

🧪 Clinical Research

👻 Ghost score 0%

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OneTrust

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

📋 Compliance

☁️ SaaS

🏢 Enterprise

💰 $150M Series D - OneTrust on 2023-07

Compliance • SaaS • Enterprise

OneTrust is a company that provides a privacy, security, and governance software platform. Its cloud-based (SaaS) offering helps organizations manage data privacy, consent, regulatory compliance, vendor/third-party risk, and related governance and security processes, primarily for enterprise customers.

📋 Description

• Develop clinical evidence generation and dissemination strategies across assigned New Product Development and Life-Cycle Management projects • Collaborate with Clinical R&D, R&D, Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics, and Market Access partners • Align evidence strategies with regional Medical Director Clinical R&D leads and strategically important countries/regions • Develop and draft clinical trial protocols, informed consents, investigator brochures, and other study materials • Plan study budgets and collaborate with Clinical Operations on investigator agreements, site contracts, vendor agreements, payments, and financial disclosures • Deliver assigned clinical programs on time, within budget, and in compliance with regulations and SOPs • Partner with Clinical Operations and BSDM teams to optimize engagement and deliver clinical project commitments • Maintain relationships with study core teams and identify and communicate project issues to leaders • Draft annual reports, study close-out reports, and clinical sections for IDE, PMA, 510(k), and other regulatory submissions • Critically assess literature and draft Clinical Evaluation Reports for new products • Support clinical scientific discussions with regulatory agencies and notified bodies • Interpret and disseminate evidence through abstracts, manuscripts, CSRs, and market access and reimbursement activities • Foster relationships with key investigators • Ensure clinical trial registration and results posting on ClinicalTrials.gov • Develop understanding of the pipeline, product portfolio, and business needs • Keep management informed of developments and issues affecting clinical strategy and portfolio management • Communicate business issues or opportunities to the next management level • Ensure compliance with applicable federal, state, local, and Company regulations, policies, and procedures • Perform other duties as assigned

🎯 Requirements

• A Bachelor’s or equivalent degree in Biological Science or related discipline • Minimum of 6 years of related scientific, technical, or clinical research experience • Understanding of Good Clinical Practices (GCP) • Understanding and application of regulations and standards applied in clinical areas/regions • Good presentation skills and ability to effectively influence others • Written and oral communication skills • Leadership in a professional and ethical manner • Technical writing skills • Good understanding of clinical research science and processes • Understanding of product development processes, team dynamics, healthcare market environment, clinical trends, and global clinical trial regulations • Ability to provide scientifically strategic and clinical research input across NPD and LCM projects • Proven track record delivering clinical projects in a clinical/surgical research setting on time, within budget, and in compliance with SOPs and regulations • Ability to lead study teams and deliver critical milestones • Ability to collaborate across Clinical R&D functional areas and meet business objectives • Ability to build collaborative relationships with internal and external partners and stakeholders • Ability to influence, shape, and lead without direct reporting authority • Must follow applicable laws, policies, compliance requirements, and professional standards

🏖️ Benefits

• Consolidated retirement plan (pension) • Savings plan (401(k)) • Eligibility to participate in the long-term incentive program • Vacation – 120 hours per calendar year • Sick time – 40 hours per calendar year; 48 hours per calendar year for employees residing in Colorado; 56 hours per calendar year for employees residing in Washington • Holiday pay, including Floating Holidays – 13 days per calendar year • Work, Personal and Family Time – up to 40 hours per calendar year • Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child • Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year • Caregiver Leave – 80 hours in a 52-week rolling period • Volunteer Leave – 32 hours per calendar year • Military Spouse Time-Off – 80 hours per calendar year