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Data Management Lead (Bloemfontein,Centurion or Home-based, S.A.)

Employer
Parexel
Location
South Africa
Salary
Competitive
Start date
28 Nov 2020
Closing date
7 Dec 2020

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Discipline
Data Management / Statistics
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Job Description

Job Purpose:
The Data Management Lead
* has overall accountability for the execution of the Data Management strategy from database setup through database lock and the Data Management technology set-up for the project.
* can competently and independently lead large, complex projects and/or programs.
* provides leadership and expertise in all aspects of Data Management and Clinical Data and Database Programming.
* The Senior Data Management Lead manages the delivery of all relevant data operations activities from database setup through database lock and data transfers.

General areas of responsibility include: coordination of the relevant Data Operations team members and their activities across all geographies, liaising with project leadership, other functional leaders (clinical, biostatistics, medical, medical writing etc.) and the client as a single point of contact to ensure that the contracted data deliverables are being met - specifically in terms of timeliness, financial management and quality. May act as Project Leader for projects involving a small number of services, where no Project Leader is assigned. May cover for the Clinical Operations Lead, if appropriately trained in the corresponding tasks.

Key Accountabilities:
Accountability Supporting Activities
* Provide leadership to ensure the project or program is completed within budget, schedule and according to contract specifications. Ensure the project/program is progressing according to quality standards, SOP's, ICH and/or other guidelines to fulfill regulations
* Must manage time, and understand financials, maintain focus on quality, balancing deadlines with ensuring high quality output maintenance of relevant data operations project documentation.
* Thorough knowledge of numerous EDC systems (DataLabs, InForm, Rave)
* Thorough knowledge of electronic source data capture systems (e.g. ClinBase)
* Thorough knowledge of the eClinical suite and additional tools and systems that can be integrated with a particular EDC system
(MyTrials, IVRS etc) and Reporting functionality within the EDC system)
* Thorough knowledge of all DB set- up activities including but not limited to Database Configuration Specifications, Data Validation
* Thorough knowledge of all activities during Study Maintenance and Database Lock. Review of metrics to determine risks and risk mitigation plans as required
* Effectively communicate to and manage internal project teams, external customers and third party vendors. Hold team meetings on a regular basis. Participate in client, investigator and team meetings. Ensure interdependencies are understood, anticipate potential barriers or issues, and put plan in place with appropriate countermeasures
* Effectively manage contracted project delivery. Highlight issues/risks to delivery and mitigate risks for both Parexel and the client, developing contingency plans for the project (or providing input to PL). Accountable for quality control of project deliverables and timely delivery of projects.
* Manage appropriate project level resourcing of staff and staff assignments. Identify and request staff necessary for the project team.
* Ensure information entered into management systems is accurate and updated on a regular basis.
* Review metrics reports regularly, determine the cause of any project overruns, track scope of ongoing work to identify and raise CIS in a timely manner.
* Participate in cross functional meetings and drive initiatives, participate in Business Development and BID Defense meetings as required.
* Prepare, participate in and follow up on audits/inspections.
* Participate in meeting with Business Development / PFD / PL to understand the scope of the contract and any Master Service Agreement in place for the client
* Collaboration with the Clinical team to review the ClinBase setup performed by the pharmacy, safety Laboratory team and Clinical Database Designer.Qualifications

Skills:
Leadership skills that include:
o Building and leading global (virtual) teams
o Ability to work effectively with and motivate virtual teams
o Ability to negotiate and influence in order to achieve mutually beneficial results
o Proven problem solving skills
o Strong communication skills with a diplomatic approach
o Strong ability to manage multiple and varied tasks with enthusiasm, prioritize workload with attention to detail
o Effective time management in order to meet objectives
o Ability to conduct root cause analysis in business problem solving and process improvement development
o Ability to make appropriate decisions in ambiguous situations

Personal skills that include:
o Excellent interpersonal, oral and written communication skills
o Ability to gain trust and confidence with a variety of clients as well as within Parexel
o Excellent learning ability
o Managerial courage, resilience, and ability to adjust to a rapidly changing environment
o Excellent presentation skills
o Work with integrity
o Ability to travel as required

Business / Operational skills that include:
o Strong customer focus, ability to interact professionally within a client organization
o Understanding of Parexel project financial tools, reports and processes for management of project financials with regards to forecasting, revenue recognition, scope of work and department budget for assigned projects.
o Commitment to quality
o Understanding of Global Data Operations tasks, specifically within Data Management and Database Programming and relevant data standards
o Sound awareness of relevant regulations, including ICH-GCP, 21CRF11
o Excellent technical skills including but not limited to the knowledge of Clinical Trial/Data Management Systems, PMED, IVRS
o Basic knowledge of SAS

Knowledge and Experience:
* Substantial experience in clinical research
* Proven record of leading project and program teams in a technical/programming or data processing environment
* Strong understanding of cross functional activities
* Strong customer service focus
* Robust knowledge of ICH-GCP Guidelines, local regulatory requirements and Parexel SOP's and study specific procedures

Education:
* Bachelor's degree and / or other qualifications in a science or industry related discipline
* Competent in written and oral EnglishWhy Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

Company

Parexel International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, Parexel has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Parexel Informatics, Inc., a subsidiary of Parexel, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process.

 

Mission: Parexel’s mission is to combine the strength of our expertise, experience and innovation to advance the worldwide success of the bio/pharmaceutical and medical device industries in preventing and curing disease.

 

Company info
Website
Telephone
+44 1895 238000
Location
The Quays
101-105 Oxford Road
Uxbridge
Middx
UB8 1LZ
GB

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