Site Care Partner I

0-2 years

Not Disclosed

India Remote

10 Feb. 7, 2025

Job Description

Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Site Care Partner I

Job ID: R0000029686
Category: Clinical Trials
Location: India, Remote
Date Posted: 01/07/2025

Key Responsibilities:

1. Site Start-Up and Activation:

Site Qualification and Activation: Deploy GSSO site strategies by qualifying and activating assigned sites.
Site Selection Activities: Support processes for country & site selection, including reviewing and assessing the draft site list and providing PTA output for site selection.
Feasibility and Outreach: Collaborate with stakeholders to provide country/regional-level input for protocol feasibility, country SOC, and medical practices.
Study Knowledge: Maintain thorough knowledge of assigned protocols.
Study Start-Up: Coordinate study start-up activities at the site level, including PTA, site activation checklist items, ICD finalization, and SIV management.

2. Site Initiation and Documentation:

Site Training & Documentation: Ensure all site initiation activities are completed, including training, documentation, and systems needed for site activation (e.g., PSR, SART, ESRA, SAC, FU Letter, Planisware, ISF/eISF, etc.).
ICD Review and Deployment: Support country-specific ICD review and deployment when applicable.
Site Monitoring Readiness: Ensure follow-up activities are completed post-PTA and SIV to ensure site readiness for FSFV.

3. Site Management and Support:

Relationship Building: Foster strong relationships and operational oversight with investigator sites.
Escalated Issues: Provide support for escalated site issues related to study delivery (e.g., vendor, site contracts, payment issues).
IP and Ancillary Supplies: Oversee IP and ancillary supplies strategy for sites and ensure compliance with country requirements throughout the study lifecycle.
Enrollment Support: Be accountable for effective site recruitment planning, delivery, and ensuring progress by addressing recruitment issues from investigators.

4. Communication and Collaboration:

Status Updates: Maintain regular communications with investigator sites to gather status updates and drive study goal delivery (e.g., recruitment, data entry timelines).
Local Collaboration: Partner with local RA/CTRO/SAP to ensure timely completion of country/local registry when applicable.

5. Study Conduct and Close-Out:

Operational Point of Contact: Serve as the operational point of contact for all site-level questions and escalate to appropriate teams when necessary.
Site Monitoring Reports: Review site monitoring reports and assist with revisions and submissions of ICD documents (and amendments).
System Management: Manage system platforms (e.g., EDC, Shared Investigator Platform, Site Profile) to ensure alignment across platforms.
SMO Assessment: Review and update the SMO Assessment annually or when significant site changes occur.

6. Site Performance and Compliance:

Oversight of Site Deliverables: Ensure site deliverables are met, including data cuts, interim analyses, database locks, and investigator signatures.
Risk Mitigation: Follow the study oversight plan and proactively implement mitigations for known/anticipated risks.
Decentralized Capabilities: Support the development and delivery of decentralized capabilities at investigator sites (e.g., home health, ePRO, DTP).

7. Monitoring and Best Practices:

Monitoring Efficiency: Drive monitoring efficiencies and best practices for the study, region, and program.
Client Reputation: Support shaping the local clinical development environment to enhance Client's scientific leadership reputation.
Site Performance Improvements: Actively pursue possible efficiencies and develop best practices to improve site performance throughout the study lifecycle.

8. Investigator Relationship Management:

Investigator Relationship Development: Build and maintain positive investigator relationships and escalate any training or compliance concerns with the Country Trials Manager and Study Management.
Site Intelligence: Proactively provide local intelligence based on in-depth understanding of country/region, sites, processes, and performance metrics.

9. Local Requirements and Import/Export Support:

Site Recommendations: Provide input into site recommendations based on local knowledge and site performance metrics.
Import/Export Support: Support the Study Operations Manager/Global Study Manager in defining local requirements for the importation/exportation of investigational medical products and ancillary supplies.

Qualifications:

Education:

Required: Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience (minimum of 5 years of experience).
Preferred: Proficiency in the local language; English is required.

Prior Experience:

Site Management: Demonstrated experience in site management, with prior experience as a site monitor.
Study Start-Up: Experience in study start-up activities through to site activation.
Study Conduct and Close-Out: Proven experience in conduct and close-out activities.
Regulatory Knowledge: Knowledge of quality and regulatory requirements in applicable countries.

Technical Competencies:

Clinical Guidelines: Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and other applicable regulatory requirements.
Computer Skills: Strong computer skills and the ability to embrace new technologies.
Communication Skills: Excellent communication, presentation, and interpersonal skills.
Travel Requirement: Ability to manage required travel of up to 75% on a regular basis.
Networking & Relationship Building: Demonstrated ability to manage cross-functional relationships and build effective relationships with investigator site staff.

Behavioral Competencies:

Problem-Solving: Ability to overcome barriers encountered during the implementation of new processes and systems.
Effective Communication: Ability to communicate effectively with colleagues, associates, and external stakeholders.
Adaptability: Ability to adapt to changing technologies and processes.
Relationship Building: Build and maintain effective relationships with investigator site staff and other stakeholders.

Additional Information:

Remote Role: This position is remote, allowing flexibility in work location.

Latest Jobs

Associate Director (Group Head), Clinical Data Acquisition And Management (Clinical Data Science)

Novartis

Hyderabad India

Pharma Jobs in India

Andra Pradesh :

Assam :

Dibrugarh | Diburghar | Guwahati |

Bihar :

Hajipur | Patna |

Chhattisgarh :

Bilaspur | Eot Municipality | Raipur |

Delhi :

Delhi | India | New Delhi | PAN-India |

Goa :

Goa | Panaji | Verna |

Gujarat :

Haryana :

Himachal Pradesh :

Baddi | Solan |

India :

Siliguri |

Jharkhand :

Ranchi |

Karnataka :

Kerala :

Madhya Pradesh :

Maharashtra :

Odisha :

Bhubaneswar | Rourkela |

PAN-India :

Panjab :

Pondicherry (Puducherry) :

Pondicherry (Puducherry) |

Punjab :

Rajasthan :

Sikkim :

Rangpo |

Tamil Nadu :

Uttar Pradesh :

Uttarakhand :

Dehradun | Nainital | Rishikesh | Roorkee |

West Bengal :

Digha | Kolkata | Mukundapur |

Pharma Jobs in United States

Alabama :

Birmingham |

Alaska :

Albama :

Tuscaloosa |

Arizona :

Arkansas :

Fort Smith |

California :

Colorado :

Boulder | Denver | Westminster |

Connecticut :

D.C :

Washington |

Delaware :

Wilmington |

Florida :

Georgia :

Atlanta | Rome |

Hawaii :

Hilo | Honolulu |

Idaho :

Boise |

Illinois :

Indiana :

Bloomington | West Lafayette |

Kansas :

Garden city | Kansas City | Lawrence | McPherson |

Kentucky :

Edgewood | Ft MItchell | Louisville | Shelbyville |

Kington :

Frank Scottile Blvd |

LA :

Baton Rouge | Monroe | New Orleans |

Louisiana :

Lake Charles | Shreveport |

Maine :

Bangor | Brewer |

Maryland :

Massachusetts :

Michigan :

Detroit | Houghton Lake |

Minnesota :

Missouri :

Fulton | Milan | St. Louis |

Nebraska :

Hebron | Nebraska City |

Nevada :

Las Vegas | Tonopah | Tonopsh | Virginia |

New Hampshire :

Lebanon | Manchester |

New Jersey :

New Mexico :

Farmington | Santa Fe | Tucumcari |

New York :

North Carolina :

Concord | Lumberton | North Carolina |

North Caroline :

North Dakota :

Dickinson |

northeastern :

New Hampshire |

Ohio :

Oklahoma :

Oklahoma City |

Oregon :

Pennsylvania :

Portugal :

Lisbon | Oeiras | Portugal |

Puerto Rico :

San Juan |

Republic of Mexico :

Mexico |

South Carolina :

Charleston |

Tennessee :

Memphis | Nashville |

Texas :

United states :

fairmont | Georgia | OH | United States |

United States :

Hawai | kentucky | Sylmar | Woonsocket |

Virginia :

Blacksburg | Charlottesville | Falls Church |

Washington :

WI :

Madison | Wausau |

Wisconsin :

Portage |

Wyoming :

Big Piney | Cokeville |

Pharma Jobs in Germany

Baden-Wurttemberg :

Bavaria :

Berlin :

Mitte |

Brandenburg :

Berlin |

Germany :

Germany | GErmany |

Hesse :

Darmstadt | Marburg |

Hessen :

Frankfurt | Harveysburg |

Lower Saxony :

Gottingen | Hannover | Leipzig |

Mecklenburg Vorpommern :

Rostock |

Munich :

Bavaria |

North Rhine Westphalia :

Rhineland Palatinate :

Ingelheim am Rhein | Mainz |

Rotherbaum :

Hamburg |

Saarland :

Saarbrucken |

Saxony Anhalt :

Halle |

Schleswig Holstein :

Kiel |

Pharma Jobs in Europe

Belgium :

Wavre |

BULGARIA :

Bulgaria |

Denmark :

Copenhagen | Denmark |

Europe :

Finland :

Finland |

Hungary :

Budapest |

Istanbul :

Istanbul | Turkey |

Norway :

Norway | NOrway |

Romania :

Romania |

Serbia :

Belgrade | Serbia |

Switzerland :

Basel | Zurich |

Pharma Jobs in China

China :

China | Quarry Bay |

Hubei :

Wuhan |

Liaoning :

Dalian |

Republic of China :

Beijing |

Shanghai Sai :

Shanghai Shi |

Tokiyo :

Osaka | Tokyo |

Zhejiang :

Hangzhou |

Pharma Jobs in Australia

Melbourne :

South Yarra |

New South Wales :

Ballina | Sydney |

Queensland :

Queensland |

Remote Australia :

Remote Australia |

Republic of Western Australia :

Nedlands |

Pharma Jobs in Ireland

Cork :

Ringaskiddy |

County Dublin :

Swords |

Dún Laoghaire :

Dún Laoghaire |

Republic of Ireland :

Cork | Dublin | Limerick | Waterford |

Ulster :

Donegal |

Pharma Jobs in Netherland

Capital of Netherland :

Amsterdam |

Netherlands :

Netherlands |

Noord Holland :

Haarlem |

North Brabant :

Breda |

South Holland :

Leiden |

Pharma Jobs in United Kingdom

Antrim :

Larne |

Cheshire :

Runcorn |

Hertfordshire :

Welwyn |

Surrey :

Pirbright |

Pharma Jobs in Argentina & Austria & Belgium & Bosnia and Herzegovina & Bulgaria & Canada & Chile & Colombia & Croatia & Czechia & Egypt & England & Estonia & Federated States of Micronesia & Finland & France & Greece & Indonesia & Israel & Italy & Japan & Kazakhstan & Korea & malaysia & Mexico & Peru & Philippines & Poland & Portugal & Remote & Romania & Saudi Arabia & Serbia & Singapore & South Afrcia & South America & Spain & Sweden & Taiwan & Tennessee & Thailand & Turkey & Ukraine & United Arab Emirates & Vietnam

Buenos Aires :

Buenos Aires |

Austria :

Austria |

Vienna :

Vienna |

Antwerp :

Heist op den Berg |

Brussels :

Brussels |

Flemish Brabant :

Zaventem |

Bosnia and Herzegovina :

Sarajevo |

Sofia City :

Sofia |

Canada :

Canada |

Ontario :

Quebec :

Montreal |

Chile :

Santiago |

Republic of Colombia :

Bogota |

Croatia :

Croatia |

Zagreb :

Zagreb |

Bohemia :

Prague |

Republic of Egypt :

Cairo |

Oxfordshire :

Witney |

South Yorkshire :

Sheffield |

United Kingdom :

Estonia :

Estonia | Tartu |

Harju County (Maakond) :

Tallinn |

Chuuk :

North Ostrobothnia :

Oulu |

Southwest Finland (Varsinais-Suomi) :

Turku |

France :

Paris | Lyon |

Attica :

Athens | Koropi |

Greece :

Greece |

East Java :

Surabaya |

Jakarta :

Jakarta |

Israel :

Italy :

Italy |

Lombardy :

Rho |

Japan :

Japan |

Tokyo :

Otemachi |

Kazakhstan :

Almaty |

Remote Korea :

Remote Korea |

Republic of Korea :

Seoul |

Kuala Lumpur :

Kuala Lumpur |

Mexico :

Ciudad de México |

Lima Region :

Lima |

Cebu Province :

Cebu City |

Philippines :

Manila |

Mazovia :

Warsaw |

Remote :

Bucharest :

Bucharest |

Makkah :

Nišava District :

Niš |

Singapore :

Singapore |

South Africa :

South Africa | Midrand |

Brazil :

Sao paulo | Brazil |

South America :

Argentina | Peru |

Catalonia :

Barcelona |

Madrid :

Madrid |

Sweden :

Sweden |

Taipei :

Taipei |

Williamson :

Brentwood |

Republic of Thailand :

Bangkok |

Kyiv Oblast :

Kyiv |

Dubai :

Dubai |

Hà Nội :

Hanoi | Hà Nội |

Ho Chi Minh :

Ho Chi Minh City |