Upload Button Icon Add office photos
Engaged Employer

i

This company page is being actively managed by Fortrea Development India Private Limited Team. If you also belong to the team, you can get access from here
3.9

based on 677 Reviews

filter salaries All Filters

30 Fortrea Development India Private Limited Jobs

Associate Clinical Data Manager

6-8 years

₹ 6.75 - 12.5L/yr (AmbitionBox estimate)

tooltip
This is an estimate of the average salary range for this position. It has not been reviewed by the company, and the actual salary may differ.

Bangalore / Bengaluru

1 vacancy

Associate Clinical Data Manager

Fortrea Development India Private Limited

posted 1d ago

Job Description

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Job Overview:
Data Management leadership on studies and take responsibility for the development of the project documentation, system set-up, data entry and data validation procedures and processes assigned to more junior staff. Assume responsibility for all DM activities (from study start-up to database lock) according to client quality expectations, within project timelines and budgets. Work directly with Sponsors to understand their direct requirements and lead implementation of those requirements. Regularly review client specific process to ensure they remain optimal for Sponsor and Fortrea.
Summary of Responsibilities:
  • Lead studies including (but not limited to) a combination of healthy volunteer and patient populations, multi-site, client management required or reduced timelines. Ability to organize and effectively prioritize workload and deliverables.
  • Be accountable for all DM deliverables as assigned per the established timeline; providing instruction to their DM study team(s) and review of their study team s output to ensure the highest quality, while adjusting resource allocations accordingly.
  • Ensure that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs.
  • Work with the Project Manager(s) to build timelines to meet contracted milestones by communicating with leads in different disciplines and the full project team as necessary, including at study initiation meetings.
  • Provide DM project team leadership and accountability; leads data focused internal project team meetings; meets frequently with the study leads of EDC Design, SAS Programming, Statistics, and PK to ensure that all deliverables are planned and coordinated intradepartmental; proactively identifies potential risks/mitigations, effectively communicates data-driven discussions in order to achieve database lock dates; keeps the Project Manager apprised of project progress.
  • Maintain awareness of other Biometrics functional group deliverables to be able to support risk and mitigation strategies, including impact on DM resources or deliverables and consult with Project Manager (or designee) and/or functional group management as necessary.
  • Keep Project Manager (or designee), Biometrics management team and/or sponsor services informed of pertinent project or sponsor related information (i.e., budget status, work scope changes, timeline impacts). Performs other related duties as assigned by Line Management.
  • Develop and maintain client relationships and review client satisfaction surveys.
  • Track scope changes and work with the Project Manager to ensure that Sponsor approval is received, and the scope change processed.
  • Provides leadership, mentorship, and coaching in DM related clinical trial processes to the internal study team.
  • Provide support to DM managers on the performance evaluation of other team members, provide constructive feedback to aid in career development, interpersonal skills and achievement of competency standards.
  • Accountable for learning new DM technologies and applied processes, keeping up to date with industry wide technology and feasibility for process improvement at Fortrea.
  • Maintain accurate records of all work undertaken.
  • Perform reconciliation of the clinical database against safety data, laboratory data or any other third-party data as appropriate. Utilize local laboratory systems and batch data load facilities where appropriate.
  • Represent DM and where necessary overall Biometrics in new business opportunities.
  • Attend and action client or internal audits as appropriate and resolve all issues within an appropriate timeframe. Address client comments with the study team.
  • Actively promote Biometrics services to sponsors whenever possible.
  • All other duties as needed or assigned.
Qualifications (Minimum Required):
  • University / college degree.
  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
  • Experience and/or education plus relevant work experience, equating to a bachelors degree will be accepted in lieu of a bachelor s degree.
  • Fluent in English, both written and verbal.
Experience (Minimum Required):
  • 6 to 8 years of DM experience with minimum of 1 years of direct sponsor management.
  • Experience in handling customer concerns and experience with managing Scope of Work and budgets is preferred.
  • Knowledge of clinical trial process, DM, clinical operations, biometrics, and system applications to support operations.
  • Time management skill and ability to adhere to project productivity metrics and timelines.
  • Ability to work in a team environment and collaborate with peers.
  • Good organizational ability, communication, and interpersonal skills.
  • Team working skills and good collaborator skills.
  • Knowledge of medical terminology.
Preferred Qualifications Include:
  • University / college degree in life sciences, health sciences, information technology or related subjects preferred.
  • Knowledge of science or a scientific background is preferred.
  • Thorough knowledge of Fortrea, the overall structure of the organization and Standard Operating Procedures (SOPs).
  • 3+ years of Electronic Data Capture experience.
Physical Demands/Work Environment:
  • Office and home-based work environment.
  • May require overtime and weekend work as required.
  • Should be willing to work in flexible shifts as per business requirement.

Employment Type: Full Time, Permanent

Read full job description

Fortrea Development India Private Limited Interview Questions & Tips

Prepare for Fortrea Development India Private Limited roles with real interview advice

What people at Fortrea Development India Private Limited are saying

4.4
 Rating based on 3 Associate Clinical Data Manager reviews

Likes

Work life balance

  • Salary - Excellent
    +6 more
Dislikes

None , everything is excellent

    Read 3 Associate Clinical Data Manager reviews

    Associate Clinical Data Manager salary at Fortrea Development India Private Limited

    reported by 27 employees with 6-11 years exp.
    ₹6.8 L/yr - ₹17.9 L/yr
    9% more than the average Associate Clinical Data Manager Salary in India
    View more details

    What Fortrea Development India Private Limited employees are saying about work life

    based on 677 employees
    73%
    94%
    84%
    92%
    Flexible timing
    Monday to Friday
    No travel
    Day Shift
    View more insights

    Fortrea Development India Private Limited Benefits

    Submitted by Company
    Cafeteria
    Work From Home
    Soft Skill Training
    Health Insurance
    Job Training
    Team Outings +1 more
    Submitted by Employees
    Work From Home
    Health Insurance
    Job Training
    Soft Skill Training
    Free Transport
    Cafeteria +6 more
    View more benefits

    Compare Fortrea Development India Private Limited with

    IQVIA

    3.9
    Compare

    ICON Plc

    4.2
    Compare

    PPD

    Compare

    Syneos Health

    3.9
    Compare

    Parexel International

    3.9
    Compare

    Charles River Laboratories

    3.9
    Compare

    WuXi AppTec

    3.1
    Compare

    Labcorp

    4.1
    Compare

    Syngene International

    3.9
    Compare

    Aragen Life Sciences

    4.0
    Compare

    SAI Life Sciences

    3.9
    Compare

    Qinecsa Solutions

    2.9
    Compare

    Lambda Therapeutic Research

    4.5
    Compare

    Reliance Life Sciences

    3.5
    Compare

    Aizant Drug Research Solutions

    3.9
    Compare

    Veeda Clinical Research

    3.9
    Compare

    Equinox Labs

    3.8
    Compare

    Rubicon Research

    3.3
    Compare

    Cliantha Research

    4.0
    Compare

    Accutest Research Laboratories

    3.6
    Compare

    Similar Jobs for you

    Senior Clinical Data Specialist at Fortrea

    Bangalore / Bengaluru

    4-6 Yrs

    ₹ 11-12 LPA

    Clinical Data Manager at MMS Holdings Inc.

    Remote

    2-5 Yrs

    ₹ 9-13 LPA

    Clinical Data Programmer at Clario

    Bangalore / Bengaluru

    5-10 Yrs

    ₹ 15-25 LPA

    Clinical Trial Manager at BRISTOL-MYERS SQUIBB INDIA PVT.LTD.

    Mumbai

    5-10 Yrs

    ₹ 10-13 LPA

    Clinical Trial Manager at BRISTOL-MYERS SQUIBB INDIA PVT.LTD.

    Mumbai

    5-13 Yrs

    ₹ 7-15 LPA

    Manager at BRISTOL-MYERS SQUIBB INDIA PVT.LTD.

    Hyderabad / Secunderabad

    5-6 Yrs

    ₹ 12-17 LPA

    Specialist at Accenture Solutions Pvt Ltd

    Bangalore / Bengaluru

    8-10 Yrs

    ₹ 10-15 LPA

    Specialist at Accenture Solutions Pvt Ltd

    Bangalore / Bengaluru

    7-11 Yrs

    ₹ 9-13 LPA

    Statistical Programmer Specialist at Fortrea

    Bangalore / Bengaluru

    2-7 Yrs

    ₹ 10-11 LPA

    Senior Statistical Programmer at Fortrea

    Bangalore / Bengaluru

    3-8 Yrs

    ₹ 14-15 LPA

    Fortrea Development India Private Limited Bangalore / Bengaluru Office Location

    View all
    Bengaluru Office
    MSR Vaishnavi 29 Union Street, Near Cubbon Park Metro Station, Shivaji Nagar, Bengaluru, Karnataka 560001 Bengaluru
    560001

    Associate Clinical Data Manager

    6-8 Yrs

    Bangalore / Bengaluru

    2d ago·via naukri.com

    Senior Technology Manager

    10-16 Yrs

    Remote

    2d ago·via naukri.com

    Programming Lead

    5-10 Yrs

    Mumbai, Pune, Bangalore / Bengaluru

    2d ago·via naukri.com

    Senior Statistical Programmer Specialist

    2-7 Yrs

    Bangalore / Bengaluru

    2d ago·via naukri.com

    Lead Quality Specialist

    5-10 Yrs

    Pune

    2d ago·via naukri.com

    Director, Global IT/Clinical Strategic Sourcing

    13-15 Yrs

    Bangalore / Bengaluru

    2d ago·via naukri.com

    Director, Regulatory Affairs Operations

    15-17 Yrs

    Pune

    2d ago·via naukri.com

    Site Readiness and Reg Specialist II

    3-7 Yrs

    Mumbai, Pune, Bangalore / Bengaluru

    2d ago·via naukri.com

    Contracts Specialist II, Site Agreements

    4-8 Yrs

    Bangalore / Bengaluru

    2d ago·via naukri.com

    Associate HR Business Partner

    5-8 Yrs

    Bangalore / Bengaluru

    2d ago·via naukri.com
    write
    Share an Interview