Study Start-Up Manager (FSP Sponsor-Dedicated) – Home-Based | Durham, North Carolina
Job Type: Full-Time
Work Model: Home-Based (Remote)
Location: Durham, North Carolina, with availability in additional U.S. locations
Job ID: R1514112
About the Role
IQVIA is seeking an experienced Study Start-Up Manager (FSP Sponsor-Dedicated) to lead and oversee all site activation, regulatory, and maintenance activities across assigned clinical studies or multi-protocol programs. This role requires strong leadership, regulatory expertise, cross-functional coordination, and the ability to deliver high-quality operational outcomes within established timelines and strategic frameworks.
The Study Start-Up Manager will direct pre-award, bid defense, site activation, and maintenance activities while ensuring compliance with regional and global regulatory requirements. This position plays a strategic role in managing stakeholder expectations, resource planning, and operational execution.
Key Responsibilities
Lead the delivery of site activation, pre-award, and maintenance activities according to study timelines and overall project strategy.
Develop, implement, and maintain comprehensive Management Plans aligned with the Scope of Work and Project Plan.
Ensure effective collaboration with regulatory, country, and regional teams to achieve activation milestones and maintain compliance throughout the study lifecycle.
Review and/or create technical and administrative documentation supporting business development, regulatory submissions, and study maintenance.
Provide specialized regulatory and scientific guidance to support study initiation and ensure compliance with applicable regulatory expectations.
Guide and oversee multi-regional and multi-protocol programs during the start-up and maintenance phases as a core member of the study management team.
Identify regulatory complexities early and offer strategic, practical solutions that support bid processes and execution plans.
Contribute to regulatory intelligence efforts through collection, interpretation, and dissemination of current regulatory insights.
Manage ongoing operational strategies for maintaining approvals, negotiating essential documents, and executing contract requirements.
Collaborate with Quality Management to uphold quality standards throughout site activation and maintenance.
Coach, mentor, and support team members to strengthen operational capabilities.
Maintain accurate and up-to-date data across CTMS, tracking systems, timelines, and project plans.
Support customer relationship development and represent IQVIA in presentations, training, and professional engagements.
Participate in monthly study budget planning, financial reviews, and adherence to project cost parameters.
Required Qualifications & Experience
Bachelor’s degree in Life Sciences or a related field.
Minimum 7 years of relevant experience in a scientific or clinical environment, including experience in international clinical research roles.
Strong verbal negotiation and written communication skills.
Demonstrated ability to lead cross-functional teams and deliver complex projects within defined timelines.
Comprehensive knowledge of the clinical trial environment, drug development process, GCP, ICH guidelines, and global regulatory standards.
Proficiency in digital systems, documentation tools, and study management systems (with emphasis on CTMS).
Strong regulatory and technical writing capabilities.
Proven leadership, organizational, planning, and decision-making skills.
Ability to balance multiple studies, competing priorities, and varying operational demands.
Experience managing financial aspects of study operations.
Strong relationship-building skills with internal teams, sponsors, and partners.
About IQVIA
IQVIA is a global leader in advanced analytics, clinical research services, and technology solutions for the life sciences industry. Through integrated data, technology, and deep scientific expertise, IQVIA supports the development and commercialization of innovative treatments that improve patient outcomes worldwide.
Compensation
The estimated annual base pay range for this role is $74,600 – $216,000. Actual compensation may vary based on experience, qualifications, geographic location, and work schedule. Eligible candidates may also receive incentives, bonuses, and a comprehensive benefits package.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
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Baddi | Solan |Rajasthan :
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Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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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Abilene | Arlington | Austin | Boerne | Brenham | Bulverde | Carrollton | Cedar Hill | Corpus Christi | Corsicana | Dallas | Denton | El Paso | Fort Worth | Garland | Houston | Lakeway | Longview | Mcallen | North Richland Hills | Plano | Richardson | San Antonio | Seguin | Tyler | Waco |California :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Atlanta | Augusta | Rome |Maine :
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Frank Scottile Blvd |Missouri :
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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 :
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Swords |Republic of China :
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China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
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Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
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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 :
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Montreal |Brussels :
Brussels |Antwerp :
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Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Barcelona |Madrid :
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Manila |Croatia :
Croatia |Zagreb :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Rho |Jakarta :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Bangkok |Israel :
Netanya | Kfar Saba | Yavne | Tel Aviv | Be'Er Sheva |Remote :
McFarland | Green Way | Springville | Nairobi | Remote - South America (Latin Americal) | French | Melbourne | Remote, USA | Zaragoza | Medan | Lenexa | Switzerland | Remote - Africa | Bountiful | Remote | Castlebar | Leinster | Bishop | Lousiana | Thailand | Regulatory Labeling Manager (NA and LATAM Only) | Hungary | Texas | Riga | Faridabad | Remote - Europe | Belgium | Tulsa | Minnesota | Ireland | Remote - Middle East | Hammond | Manipal | Slovakia | Victoria | Blue Bell | Xzagreb |Republic of Colombia :
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Buenos Aires |Republic of Egypt :
Cairo |Mexico :
Ciudad de México | New Mexico |Dubai :
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Rabigh | Jeddah | King Abdullah Economic City | Khulais | Najran | Riyadh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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