Study Delivery Senior Associate
Location: Hyderabad, India
Work Type: On-Site
Position Summary
The Study Delivery Senior Associate provides administrative and operational support for clinical trial management activities. This role supports Study Delivery Teams in executing clinical studies efficiently, maintaining regulatory compliance, meeting study timelines, and ensuring accurate management of clinical systems, documentation, and operational processes.
The position also contributes to specialized study support activities, helping drive consistency, quality, and operational excellence across multiple clinical trials throughout their lifecycle.
Key Responsibilities
Study Coordination & Operational Support
Support the setup, maintenance, and tracking of study-level dashboards, timelines, trackers, and operational tools.
Communicate study progress, timelines, and deliverables to the Study Delivery Manager and study teams.
Track study actions and follow up on assigned tasks to ensure timely completion.
Assist with risk identification, mitigation activities, and action tracking.
Support preparation, documentation, and maintenance of risk and quality review records.
Ensure completion of study team training requirements and inspection readiness activities.
Coordinate logistics for:
Investigator Meetings
Trial-Related Events
Global Site Communications
Support study start-up activities, including:
System Configuration and Setup
Supplier Access Management
Informed Consent Form (ICF) Tracking
Study Documentation Readiness
Site & Vendor Support
Support vendor relationship management activities.
Assist with site engagement and communication strategies.
Coordinate operational activities with external vendors and service providers.
Monitor study-related deliverables and ensure timely completion.
Sample & Investigational Product Management
Coordinate shipment, tracking, reconciliation, and analysis of biological samples.
Support management of investigational product logistics.
Ensure compliance with sample management and reconciliation procedures.
Assist with inventory tracking and documentation requirements.
Data & Systems Management
Maintain clinical trial systems, including:
Clinical Trial Management Systems (CTMS)
Study Training Systems
Other Clinical Operations Platforms
Ensure accurate and timely data entry and system updates.
Support user access requests and system access management activities.
Monitor data quality and completeness within assigned systems.
Documentation & Compliance
Assist in preparing, reviewing, and maintaining study documentation.
Support regulatory submission activities and document preparation.
Maintain study-related operational documents, including:
Monitoring Plans
Study Guides
Training Documentation
Study Records
Support Trial Master File (TMF) management and filing activities.
Ensure documentation complies with company standards and regulatory requirements.
Process Improvement & Knowledge Sharing
Contribute to process improvement initiatives across study operations.
Support standardization of study management practices.
Share knowledge, best practices, and lessons learned with team members.
Identify opportunities to improve efficiency and streamline operational activities.
Basic Qualifications
Candidates must meet one of the following requirements:
Bachelor's Degree, OR
Associate Degree with a minimum of 4 years of clinical execution experience, OR
High School Diploma/GED with a minimum of 6 years of clinical execution experience.
Preferred Qualifications
Minimum 2 years of experience in life sciences, healthcare, biotechnology, pharmaceutical, or related fields.
At least 1 year of biopharmaceutical clinical research experience gained within:
Biotechnology Companies
Pharmaceutical Organizations
Contract Research Organizations (CROs)
Experience supporting global clinical trials.
Familiarity with clinical trial operations and study management processes.
Experience working with CTMS, TMF, and other clinical systems.
Understanding of clinical trial documentation and regulatory requirements.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak | Shivalik |Punjab :
amritsar | Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Punjab | Rajpura |Andra Pradesh :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Madhya Pradesh :
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Bhubaneswar | Rourkela |Chhattisgarh :
Bilaspur | Eot Municipality | Raipur |Uttarakhand :
Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | Gangtok | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Goa :
Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
Fort Smith |Kington :
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 :
San Juan |Albama :
Tuscaloosa |D.C :
Washington |Delaware :
Wilmington |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Munich :
Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
Gottingen | Hannover | Leipzig |Saxony Anhalt :
Halle |Rotherbaum :
Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
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 :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
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 :
Breda |Noord Holland :
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 :
Richmond Hill | Mississauga | Uxbridge | Renfrew | Australia | North York |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |Attica :
Koropi | Athens |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 :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Be'Er Sheva | Netanya | Yavne | Kfar Saba | Tel Aviv |Remote :
Hungary | McFarland | Medan | Nairobi | Castlebar | Remote - Middle East | Riga | Slovakia | Victoria | Remote - Europe | French | Remote - South America (Latin Americal) | Leinster | Zaragoza | Melbourne | Thailand | Hammond | Ireland | Blue Bell | Texas | Bountiful | Remote - Africa | Faridabad | Switzerland | Xzagreb | Tulsa | Bishop | Milwaukee | Springville | Perth | Lenexa | Lousiana | Green Way | Regulatory Labeling Manager (NA and LATAM Only) | Minnesota | Manipal | Belgium |Republic of Colombia :
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Brentwood |Bucharest :
Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
Dubai |Makkah :
Khulais | Jeddah | Najran | King Abdullah Economic City | Rabigh | Riyadh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
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