Senior Clinical Data Associate (External Data Associate)

Syneos Health

5+ years

Not Disclosed

Remote

10 Oct. 1, 2025

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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:

Senior Clinical Data Associate (External Data Associate)

Location:

IND – Remote

Job ID:

25101749

Company Overview:

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success. We transform clinical, medical affairs, and commercial insights into actionable outcomes to address modern market realities.

Our Clinical Development model places the customer and patient at the center, continuously simplifying processes to make Syneos Health easier to work with. Whether in a Functional Service Provider or Full-Service environment, employees collaborate as passionate problem solvers to deliver life-changing therapies.

Employees: 29,000 across 110 countries
Mission Statement: Work here matters everywhere

Why Join Syneos Health:

Career development and progression opportunities
Supportive line management and training
Peer recognition and rewards programs
Inclusive Total Self culture fostering authenticity and belonging

Job Responsibilities:

Core Responsibilities:

Collaborate with Data Management (DM) and DM Quality Leads (DMQL) to manage vendor/data types using Veeva vendor tracker.
Create DTS and DTA based on vendor tracker using P21 standards.
Generate DS requests for missing standards.
Perform import review for test and production transfers, including milestone checks.
Implement protocol amendments and new requirements.
Conduct eCOA device UAT and create UAT test scripts.
Perform key mappings/unblinding rules.
Follow Good Documentation Practices (GDP) and ETMF review/approval processes.

Additional Responsibilities:

Maintain awareness of contract and scope of work; communicate status to Project Manager (PM) or Biometrics Project Manager (BPM).
Adhere to study-specific Data Management Plan (DMP).
Create and enter test data for User Acceptance Testing (UAT) across different study roles.
Review lab normal ranges and perform discrepancy (edit check) outputs.
Handle Data Clarification Forms (DCFs) for paper studies; perform internal QC checks.
Conduct DM quality reviews for EDC studies.
Participate/lead internal meetings, in-process review meetings, audits, and inspections.
Manage study file documentation in Data Management Study File (DMSF).
Perform SAS mapping QC, post-migration testing, and reconciliations of external datasets (lab, PK, IRT, eDiary).
Run data cleaning/status reports, perform SAE reconciliations, and create ad-hoc data cleaning reports.
Review database design specifications (CRF/eCRF, visit structure, DVS/edit checks).
Provide support to PDM and may serve as backup for specific activities.
Train and mentor DM staff, conduct EDC training, and serve as platform/process Subject Matter Expert (SME).
Ensure adherence to corporate practices, SOPs, and working instructions.

Qualifications:

BA/BS degree in biological sciences or related health/natural science disciplines
5+ years of experience in external data handling
Client-facing experience required
Proficiency with P21 standards, eCOA, ePRO, Microsoft Office Suite
Familiarity with medical terminology and clinical research processes
Knowledge of clinical trial process (Phases II-IV) and ICH GCP guidelines
Strong organizational, planning, and time management skills
Excellent communication, presentation, and interpersonal skills
Leadership, mentoring, and training experience in data management

Additional Requirements:

Ability to multitask under tight deadlines and adapt to changing priorities
Ability to work independently and in a multidisciplinary team
Minimal travel required (up to 25%)

Impact & Contribution:

Lead other Clinical Data Associates in all data management activities.
Support Project Data Manager (PDM) as needed.
Ensure high-quality data management deliverables for global clinical trials.

Company Highlights:

Worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products
Supported 200+ studies across 73,000 sites and 675,000+ trial patients

Website: Syneos Health

Job Category:

Clinical Data Management / Data Operations / Clinical Operations

Recommended Jobs

Pharma Jobs in India

Gujarat :

Maharashtra :

Haryana :

Andra Pradesh :

Tamil Nadu :

Himachal Pradesh :

Baddi | Solan |

Rajasthan :

Karnataka :

Punjab :

Madhya Pradesh :

Odisha :

Bhubaneswar | Rourkela |

Chhattisgarh :

Bilaspur | Eot Municipality | Raipur |

Uttarakhand :

Delhi :

Delhi | India | New Delhi | PAN-India |

Assam :

Dibrugarh | Diburghar | Guwahati |

West Bengal :

Digha | Kolkata | Mukundapur |

Uttar Pradesh :

Goa :

Goa | Panaji | Verna |

Bihar :

Hajipur | Patna |

Kerala :

Pondicherry (Puducherry) :

Pondicherry (Puducherry) |

Jharkhand :

Ranchi |

Sikkim :

Rangpo |

India :

Siliguri |

Pharma Jobs in United States

Illinois :

Maryland :

Texas :

California :

New York :

New Mexico :

Albuquerque | Farmington | Santa Fe | Tucumcari |

Pennsylvania :

Alaska :

Massachusetts :

Wisconsin :

United states :

Georgia :

Atlanta | Augusta | Rome |

Maine :

Bangor | Brewer |

New Jersey :

Ohio :

LA :

Baton Rouge | Monroe | New Orleans |

Washington :

Oregon :

Wyoming :

Big Piney | Cokeville |

Alabama :

Birmingham |

Virginia :

Blacksburg | Charlottesville | Falls Church | Mechanicsville |

Indiana :

Bloomington | West Lafayette |

Florida :

Idaho :

Boise |

Colorado :

Boulder | Denver | Westminster |

Connecticut :

North Caroline :

Arizona :

South Carolina :

Charleston |

Kansas :

North Carolina :

Concord | Lumberton | North Carolina |

Michigan :

Detroit | Houghton Lake | Macomb | Southfield |

North Dakota :

Dickinson |

Minnesota :

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 :

Knoxville | Memphis | Nashville |

Louisiana :

Lake Charles | Shreveport |

Nevada :

Las Vegas | Tonopah | Tonopsh | Virginia |

New Hampshire :

Lebanon | Macon | Manchester |

Portugal :

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 |

Pharma Jobs in Germany

North Rhine Westphalia :

Munich :

Bavaria |

Bavaria :

Brandenburg :

Berlin |

Baden-Wurttemberg :

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 |

Pharma Jobs in Europe

Switzerland :

Basel | Zurich |

Serbia :

Belgrade | Serbia |

Hungary :

Budapest |

BULGARIA :

Bulgaria | Vedant |

Denmark :

Copenhagen | Denmark |

Europe :

Finland :

Finland |

Istanbul :

Istanbul | Turkey |

Norway :

Norway | NOrway |

Romania :

Romania |

Belgium :

Wavre |

Pharma Jobs in Ireland

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 |

Pharma Jobs in China

Republic of China :

Beijing |

China :

China | Quarry Bay |

Liaoning :

Dalian |

Zhejiang :

Hangzhou |

Tokiyo :

Osaka | Tokyo |

Shanghai Sai :

Shanghai Shi |

Hubei :

Wuhan |

Pharma Jobs in Netherland

Capital of Netherland :

Amsterdam |

North Brabant :

Breda |

Noord Holland :

Haarlem |

South Holland :

Leiden |

Netherlands :

Netherlands |

Pharma Jobs in Australia

Remote Australia :

Arkansas | Remote Australia |

New South Wales :

Ballina | Sydney |

Republic of Western Australia :

Nedlands |

Queensland :

Queensland |

Melbourne :

South Yarra |

Pharma Jobs in United Kingdom

Surrey :

Chessington | Pirbright |

Antrim :

Larne |

Cheshire :

Runcorn |

Hertfordshire :

Welwyn |

Pharma Jobs in England

United Kingdom :

North Yorkshire :

Harrogate |

South Yorkshire :

Sheffield |

Oxfordshire :

Witney |

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

Ontario :

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 :

Estonia | Tartu |

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 :

Japan | Saitama |

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 :

Remote :

Republic of Colombia :

Bogota |

Williamson :

Brentwood |

Bucharest :

Bucharest |

Buenos Aires :

Buenos Aires |

Republic of Egypt :

Cairo |

Mexico :

New Mexico | Ciudad de México |

Dubai :

Dubai |

Makkah :

Kuala Lumpur :

Kuala Lumpur |

Kyiv Oblast :

Kyiv |

Lima Region :

Lima |

France :

Lyon | Paris |

South Africa :

South Africa | Midrand |

Nišava District :

Niš |

Bohemia :

Prague |

Chile :

Santiago |

Bosnia and Herzegovina :

Sarajevo |

Singapore :

Singapore |

Sofia City :

Sofia |

Sweden :

Sweden |

Taipei :

Taipei |

Mazovia :

Warsaw |

Welcome Back

Create Account

Senior Clinical Data Associate (External Data Associate)

Job Description

Recommended Jobs

Senior Medical Writer (Scientific Writing +Veeva)

Senior Medical Writer(Scientific Writer & Quality Check)

Senior Regulatory Affairs Associate

Medical Science Liaison/Senior Medical Science Liaison - Oncology - East Coast

Senior Medical Writer (Abstracts, Manuscripts)

Senior Safety Reporting Specialist

Clin Data Assoc I

Principal Medical Writer / Senior Medical Writer

Clin Data Assoc Ii

Senior Safety Reporting Specialist

Pharma Jobs in India

Pharma Jobs in United States

Pharma Jobs in Germany

Pharma Jobs in Europe

Pharma Jobs in Ireland

Pharma Jobs in China

Pharma Jobs in Netherland

Pharma Jobs in Australia

Pharma Jobs in United Kingdom

Pharma Jobs in England