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24 Fortrea Development India Private Limited Jobs

Associate Clinical Data Manager

6-8 years

₹ 6.75 - 12.5L/yr (AmbitionBox estimate)

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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 10d 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

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What people at Fortrea Development India Private Limited are saying

4.3
 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 687 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

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Fortrea Development India Private Limited Bangalore / Bengaluru Office Location

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

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