• Login / Signup
    • Instagram
    youtube
    Facebook

    Clinical Data Analyst I

    Parexel
    2+ years
    Not Disclosed
    Remote
    10 Oct. 7, 2024
    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

    About This Role

    Job Purpose:

    The Clinical Data Analyst I (CDA I) works under the guidance of their Line Manager and/or Subject Matter Experts to perform clinical data cleaning activities on assigned projects, in line with their experience and project role. Key responsibilities include supporting data processing activities and managing Data Management documents and data cleaning matrices (e.g., Data Validation Specifications, CRF Completion Guidelines, Protocol Deviation Specifications, Mock Shells for Off-line Listings). All tasks must adhere to corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP, and other international regulatory requirements.

    Key Accountabilities:

    Data Validation (Cleaning)

    • Take responsibility for or lead data cleaning and review activities (Co-Primary CDA/Primary CDA), including query management and manual/SAS listing reviews.
    • Support or begin leading data processing activities from database setup to database lock, including external vendor data reconciliation.

    Data Management Documents/Plans (Trial Master File)

    • Perform and support the setup of DM documents, ensuring proper documentation as per Standard Operating Procedures and ICH/GCP Guidelines.

    Study Start-Up Activities and User Acceptance Testing (UAT)

    • Begin leading or performing user acceptance testing on clinical database setups.
    • Review protocols and EDC Entry Screens as needed.

    Data Tracking and Entry

    • Track and review CRFs, supporting data entry as required.

    Project Quality Management & Compliance

    • Ensure compliance with Standard Operating Procedures and ICH/GCP Guidelines.
    • Support or start leading functional quality control activities on databases and/or patient data as business needs dictate.

    Training

    • Maintain training compliance as per assigned job roles, including on-the-job training.
    • Address training needs based on identified Development Goals.

    Skills:

    • Strong problem-solving skills and logical reasoning.
    • Commitment to first-time quality, demonstrating a methodical, analytical, and accurate approach to work (attention to detail).
    • Effective time management and prioritization skills to meet objectives and timelines.
    • Ability to collaborate effectively within a team environment.
    • Good interpersonal, oral, and written communication skills.
    • Quick learning ability and a knowledge-sharing approach; adaptability to new technologies and processes.
    • Flexible attitude towards work assignments and learning opportunities; ability to adjust rapidly to changing technical environments.
    • Accountability regarding key responsibilities outlined in the job description.
    • Proficiency in written and oral English.

    Knowledge and Experience:

    • Technical aptitude with basic knowledge of Microsoft Office Products.
    • Basic understanding of data management processes and data validation flows (e.g., data cleaning, database lock).
    • Familiarity with ICH-GCP Guidelines, local regulatory requirements, and Parexel SOPs and study-specific procedures.
    • Basic knowledge of Clinical Data Management Systems (e.g., InForm, Rave, Veeva, Datalabs, ClinBase).
    • Understanding of Clinical Study Team roles within Data Management.
    • Experience in the clinical research industry.
    • Basic knowledge of medical terminology and coding dictionaries (e.g., MedDRA & WHODRUG).
    • Familiarity with Data Management operational processes and tasks during study start-up, conduct, and close-out.
    • Basic understanding of database setup activities, including Database Configuration Specifications and Data Validation setup.

    Education:

    • Bachelor’s degree and/or relevant medical qualifications or industry experience.

    Latest Jobs

    Medical Science Liaison - Cardiovascular

    Bristol Myers Squibb
    Kolkata

    Medical Science Liaison - Cardiovascular

    Bristol Myers Squibb
    Kolkata

    Public Affairs - Trainee

    Novo Nordisk
    Bangalore

    Safety Surveillance Adviser I

    Novo Nordisk
    Bangalore

    Global Project Lead - Congress

    Novo Nordisk
    Bangalore

    Global Scientific Advisor

    Novo Nordisk
    Bangalore

    Senior Medical Reviewer

    Novo Nordisk
    Bangalore

    Clinical Safety Coordinator - Pharmacovigilance / Drug Safety

    Medpace
    London

    Clinical Safety Coordinator - Pharmacovigilance / Drug Safety

    Medpace
    Remote, USA

    Experienced Clinical Safety Coordinator

    Medpace
    Mexico

    Pharma Jobs in India

    Andra Pradesh :

    Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Tirupathi | Visakhapatnam |

    Assam :

    Dibrugarh | Diburghar | Guwahati |

    Bihar :

    Hajipur | Patna |

    Chhattisgarh :

    Bilaspur | Raipur |

    Delhi :

    Delhi | India | New Delhi | PAN-India |

    Goa :

    Goa | Panaji |

    Gujarat :

    Ahmedabad | Baroda | Gandhinagar | Mehsana | Tarasadi | Vadodara | Vapi |

    Haryana :

    Ambala | Hisar | Kurukshetra | Panchkula | Rohtak |

    Himachal Pradesh :

    Solan |

    Jharkhand :

    Ranchi |

    Karnataka :

    B.G Nagara | Bangalore | Belgaum | Bengaluru | Mangaluru | Mysore | Udupi |

    Kerala :

    Kannur | Kochi | Malappuram | Thiruvananthapuram |

    Madhya Pradesh :

    Dewas | Gwalior | Indore | Khandwa | Khargone | Ujjain |

    Maharashtra :

    Ambernath | Amravati | Aurangabad | Jalgaon | Kolhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane |

    PAN-India :

    Panjab :

    Punjab :

    Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |

    Rajasthan :

    Banasthali | Jaipur | Pilani | Udaipur |

    Tamil Nadu :

    Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Srivilliputtur | Tiruchirappalli | Trichy |

    Uttar Pradesh :

    Gajraula | Gautam buddha Nagar | Ghaziabad | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Varanasi |

    Uttarakhand :

    Dehradun | Nainital | Rishikesh |

    West Bengal :

    Kolkata | Mukundapur |

    Pharma Jobs in United States

    Alabama :

    Birmingham |

    Alaska :

    Anchorage | Barrow | Bethel | Juneau | Wrangell |

    Arizona :

    Chandler | Kingman | Lake Havasu City | Peridot | Phoenix | Tempe | Tucson | Yuma |

    California :

    Brisbane | Crescent City | Davis | El Monte | Emeryville | Foster City | Fremont | Irvine | La Jolla | Los Angeles | Martinez | Mountain View | Nevada | Oakland | Pacheco | Palo Alto | Pasadena | Pleasanton | Redwood City | Riverside | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | San Jose | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | Stanford | Vallejo | West Valley City | Whittier | Willits |

    Colorado :

    Denver |

    Connecticut :

    Groton | Storrs |

    D.C :

    Washington |

    Florida :

    Clearwater | Coral Gables | Gainesville | Jacksonville | Naples | Orlando | Rueil-Malmaison | Tallahassee | Tampa | West Palm Beach |

    Georgia :

    Atlanta |

    Hawaii :

    Honolulu |

    Illinois :

    Abbott Park | Champaign | Chicago | Deerfield | Lombard | Naperville | Round Lake |

    Indiana :

    Bloomington | West Lafayette |

    Kansas :

    Lawrence |

    LA :

    Monroe | New Orleans |

    Maryland :

    Baltimore | Elkridge | Gaithersburg | Rockville |

    Massachusetts :

    Boston | Cambridge | Devens | Medford and Somerville | Rockland |

    Michigan :

    Detroit |

    Minnesota :

    Minneapolis and St. Paul, Minnesota. |

    Missouri :

    Fulton | St. Louis |

    New Jersey :

    Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | West Orange | Westfield | Wharton | Whippany |

    New York :

    Biddle | Buffalo | Hicksville | Ithaca | Morningside Heights | New York | Rensselaer | Syracuse |

    North Carolina :

    Concord |

    North Caroline :

    Chapel Hills | Durham | Morrisville | Philippines | Raleigh | Scottsdale |

    Ohio :

    Cincinnati | Cleveland | Columbus, |

    Oregon :

    Bend | Corvallis | Eugene | Roseburg | Springfield |

    Pennsylvania :

    Ambler | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | West Chester | Wyomissing |

    Portugal :

    Lisbon |

    Puerto Rico :

    San Juan |

    Republic of Mexico :

    Mexico |

    Tennessee :

    Nashville |

    Texas :

    Austin | Dallas | Houston | Richardson |

    Virginia :

    Blacksburg | Charlottesville | Falls Church |

    Washington :

    Goldendale | Pullman | Seattle |

    WI :

    Madison | Wausau |

    Wisconsin :

    Wyoming :

    Cokeville |

    Pharma Jobs in Germany

    Baden-Wurttemberg :

    Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |

    Bavaria :

    Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |

    Berlin :

    Mitte |

    Brandenburg :

    Berlin |

    Hesse :

    Marburg |

    Hessen :

    Frankfurt |

    Lower Saxony :

    Gottingen | Hannover | Leipzig |

    Mecklenburg Vorpommern :

    Rostock |

    Munich :

    Bavaria |

    North Rhine Westphalia :

    Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |

    Rhineland Palatinate :

    Mainz |

    Rotherbaum :

    Hamburg |

    Saarland :

    Saarbrucken |

    Saxony Anhalt :

    Halle |

    Schleswig Holstein :

    Kiel |

    Pharma Jobs in Europe

    Denmark :

    Copenhagen |

    Hungary :

    Budapest |

    Istanbul :

    Turkey |

    Serbia :

    Belgrade |

    Switzerland :

    Basel | Zurich |

    Pharma Jobs in China

    Hubei :

    Wuhan |

    Republic of China :

    Beijing |

    Shanghai Sai :

    Shanghai Shi |

    Tokiyo :

    Osaka | Tokyo |

    Pharma Jobs in Australia & Canada & Colombia & Croatia & Egypt & England & Indonesia & Ireland & Israel & Korea & Netherland & Remote & Saudi Arabia & Spain & Thailand

    New South Wales :

    Sydney |

    Queensland :

    Queensland |

    Republic of Western Australia :

    Nedlands |

    Ontario :

    Richmond Hill | North York |

    Quebec :

    Montreal |

    Republic of Colombia :

    Bogota |

    Zagreb :

    Zagreb |

    Republic of Egypt :

    Cairo |

    United Kingdom :

    London | Harlow | Salt Lake City |

    Jakarta :

    Jakarta |

    County Dublin :

    Swords |

    Republic of Ireland :

    Dublin | Limerick | Waterford |

    Israel :

    Be'Er Sheva | Kfar Saba | Tel Aviv | Netanya |

    Republic of Korea :

    Seoul |

    Capital of Netherland :

    Amsterdam |

    Noord Holland :

    Haarlem |

    Remote :

    Remote, USA | Switzerland | Remote - Europe | Remote |

    Makkah :

    Jeddah | Khulais | Riyadh | Najran | Rabigh |

    Catalonia :

    Barcelona |

    Republic of Thailand :

    Bangkok |