Overview

Associate Global Biometrics Delivery Lead – select EMEA locations Jobs in Bloemfontein at Parexel

South Africa-Bloemfontein-Remote
South Africa, Remote
Additional Locations: Belgrade, Serbia;Bucharest, Romania;Sheffield, United Kingdom;Warsaw, Poland
Job ID R0000031333

Category Data Management

ABOUT THIS ROLE

This role can be flexibly based in select EMEA locations.

Picture Yourself At Parexel:

The Associate Global Biometrics Delivery Lead (ADL), reporting into the Global Biometrics Account lead (GBAL) or Global Biometrics Group Lead (GBGL) works under the guidance of an experienced Biometrics Delivery Leader (DL) or Line Manager receiving clearly structured directions and support and may have a client facing role

The Associate Global Biometrics Delivery Lead provides overall leadership/management for database programming, data integration, data management and statistical services on a project/program

Associate Global Biometrics Delivery Lead takes on the Biometrics Delivery Lead responsibilities for the assigned selected tasks while the overall responsibility for the management of the Data Operations activities remains with the Biometrics Delivery Lead / Account Lead. The Associate Global Biometrics Delivery Lead may work in a Biometrics Delivery Leader role (with support from the Line Manager) for reduced-scope projects

What You’ll Do At Parexel:

Global Data Organization (GDO) Strategic Support

Effectively communicate with internal and external customers as well as third party vendors

Participate in cross functional meetings and support initiatives to ensure the delivery of milestones and timelines for clinical trials

Ensure all systems both technical/non-technical are set up

Responsible for the creation and execution of a project timelines plan covering all GDO deliverables; this includes the coordination of dependencies between Data Operation stakeholders (Data Management, Programming, Biostatistics) either within Parexel or at a client

Work with study teams and Data Standards Associates to ensure enforce the use of data standards as applicable

Provide technical knowledge and oversight and serve as an escalation point where appropriate

Remain informed about developments in relevant regulations and guidelines

Team Management

Support Account Lead / Delivery Lead with Bid Defense meeting preparations as directed

Understand scope of contract and any Master Service Agreement in place for the client

Ensure the operational team reviews the draft protocol from a Data Operations perspective

Attend project kick off meetings and other project related meetings

Identify and request staff necessary for the project team

Accountable for ensuring all team members access to tools and documents as required

Ensure information entered in internal management systems is accurate and updated on a regular basis

Establish efficient/effective working relationships with other functional leaders and experts

With assistance provide leadership and direction to the project team members

Communicate project metric targets to the project team members and guide team towards achieving them

Ensure the project is progressing according to quality standards, SOPs, ICH

and/or other guidelines to fulfil regulations

Perform early risk mitigation, identifying areas of potential problems providing input into Risk Management Plan

Monitor KRIs, propose DL-led risk signal evaluations, and perform associated milestone document TMF reviews

Track resources and actual time spent on each project task for all team members to evaluate project progress and productivity

Record and measure progress of the study against project plans to mitigate risk and ensure updates are made accordingly

Implement and instigate process improvements within the project

Work with functional experts to track scope of ongoing work to identify changes in scope in a timely manner

Hold internal team meetings on a regular basis, monitoring the progress of each individual project task, and assessing the overall status of the project

May participate in client, investigator, and team meetings with support from the Delivery Lead / Account Lead

Prepare, participate in, and follow up on audits/inspections/QIs

Collaborate with Data Operations team, the Clinical Operations Leader, and other functions on project close out activities

Ensure all administrative close out procedures are completed on the project

Ensure project is archived and appropriate documentation returned to the client

Participate in end of study meetings and collate lessons learned information and feedback relevant information into the functions

Role requirements:

Several years’ experience in clinical research within CRO/Pharma/Biotech

Experience of leading a project team in a technical/programming, data management or statistical environment with supervision

Good understanding of cross functional activities

Demonstrated application of project management concepts

Bachelor’s degree in a science or industry related discipline

Fluent English

Ability to successfully manage a full workload across multiple and varied studies with enthusiasm and prioritize workload with attention to detail

Knowledge of SOPs/guidelines, ICH-GCP and other applicable local and international regulations

Understanding of the needs and use of data standards in the clinical trial environment

Ability to work effectively with and motivate virtual teams within different cultural environments

Emerging project management skills such as improving presentation skills, public speaking foundations, speaking confidently and effectively, boosting your confidence, public speaking and performance, delivery tips for speaking in public, Centered communication: get better results from your conversations, critical thinking and building trust

Proficient negotiation and diplomacy skills

Why join us:

Opportunity to work on innovative projects at the forefront of the industry

Collaborative and inclusive work environment that values your expertise

Professional advancement and development opportunities

Work life balance and flexible working hours

#LI-REMOTE

Title: Associate Global Biometrics Delivery Lead – select EMEA locations

Company: Parexel

Location: Bloemfontein

 

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