Senior Clinical Trials Specialist – Biotechnology Oncology
Location: Global | Clinical Operations – Oncology
Job Type: Full-Time
Position Overview
We are seeking a Senior Clinical Trials Specialist to join our Clinical Operations team. This role focuses on the coordination, initiation, and management of oncology clinical trials, providing operational support to the Study Delivery Lead (SDL) and ensuring seamless execution of study activities across assigned sites. The position includes oversight of external vendors, clinical research organization (CRO) collaboration, and meticulous maintenance of study documentation to support high-quality clinical trial operations.
Key Responsibilities
Coordinate oncology clinical trial activities, including study start-up, site management, and CRO oversight.
Review study documents, identify operational risks, and develop proactive mitigation strategies.
Manage clinical sites within assigned regions and support oversight of external vendors as assigned.
Monitor site start-up, protocol deviations, data quality, and CRO activities to ensure compliance with study protocols and regulatory requirements.
Assist in the development and review of study documents, including protocols, Informed Consent Forms (ICF), Vendor Oversight Plans, eCRF Guidelines, Data Review Plans, Safety Management Plans, Pharmacy Manuals, IRT specifications, and user manuals.
Develop study-specific ICF templates and assist with feasibility assessments and site selection.
Track study metrics, including site performance, recruitment, regulatory submissions, and ICF reviews.
Conduct study-specific training for vendors, site personnel, and clinical teams.
Coordinate Investigator Meetings, monitoring visit reports, clinical drug/supply reconciliation, and UAT for EDC/IRT systems.
Prepare appendices for clinical study reports and maintain internal document management systems, including timely submission to the Trial Master File (TMF).
Assist in preparation of materials for strategic governance discussions and Study Delivery Team meetings.
Education and Experience Requirements
Education:
BS/BA/BSN in Biological Sciences or related field with 5+ years of relevant experience, or
MS/MA/MSN in Biological Sciences or related field with 3+ years of relevant experience, or
Equivalent combination of education and professional experience.
Experience:
Minimum 5 years of experience in life sciences, including at least 3 years in clinical research or clinical operations.
Proven experience with oncology clinical trials and interactions with CROs, contract labs, and external vendors.
Knowledge, Skills, and Competencies
Working knowledge of clinical trial systems, including EDC, CTMS, eTMF, and interactive response technologies (IWRS, IXRS).
Strong understanding of ICH-GCP guidelines, local regulations, SOPs, and study-specific procedures.
Experience developing prospective site-selection criteria and evaluating study feasibility.
Familiarity with medical terminology and basic clinical research concepts.
Strong organizational, planning, and problem-solving skills.
Ability to communicate clearly using scientific and clinical terminology.
Advanced computer skills and proficiency in report generation.
Self-motivated, adaptable, and committed to professional development.
Ability to work effectively in a matrixed, cross-functional team environment.
Demonstrated resilience, curiosity, and systematic approach to prioritization.
Job Complexity
Works independently on problems of moderate scope requiring data analysis and judgment.
Builds productive relationships with internal teams, CROs, and external stakeholders.
Applies professional concepts, company policies, and technical standards to solve routine and complex issues.
Working Conditions
May require travel up to 20% in support of clinical study activities.
Primarily office-based with occasional site visits.
Compensation and Benefits
Competitive annual base salary: $108,500 – $153,000, adjusted based on geographic location, experience, and internal equity.
Comprehensive benefits package, including:
401(k) with company contributions
Medical, dental, and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus or incentive programs
Employee stock purchase options and long-term incentives
15 vacation days in the first year, 17 paid holidays including winter shutdown, and up to 10 sick days per year
Disclaimer
This job description outlines the primary responsibilities and qualifications for the role. It is not an exhaustive list of all duties, and additional tasks may be assigned as needed.
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Hajipur | Patna |Kerala :
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Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
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Lake Charles | Shreveport |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
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Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
New Hampshire |Oklahoma :
Oklahoma City |Puerto Rico :
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Tuscaloosa |D.C :
Washington |Delaware :
Wilmington |North Rhine Westphalia :
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Germany | GErmany |Lower Saxony :
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Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
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Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Australia | Richmond Hill | Mississauga | Renfrew | North York | Uxbridge |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
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Surabaya |Japan :
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Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
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Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
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