Senior Data Management Lead
14 hours ago
When our values align, there's no limit to what we can achieve.
Parexel are currently recruiting for a Senior Data Management Lead in South Africa.
The Senior Data Management Lead (SDML) provides leadership and expertise in all aspects of Data Management. Develop and manage timelines for study data deliveries, including Go-Live, Interim Deliveries and Final DB Lock. Collaboration with the relevant functions (Clinical, Biostatistics, Database Programming, Medical, Medical Writing etc.) across all geographies. Data Management single point of contact to ensure that the contracted Data Management deliverables are being met – specifically in terms of timeliness, financial management and quality.
The SDML Lead can competently and independently lead large, complex projects and/or programs with little to no guidance from their Line Manager and/or Subject Matter Experts. Senior DMLs may act as a mentor for Associate DMLs, DMLs and other Senior DML peers.
You may also act as Project Leader for projects involving only Global Data Operations Services.
This will be a fully remote home-based position.
Key Accountabilities:
Cross-functional DM Leadership through Database Set up, Conduct and Study Close-Out
Manage and coordinate the integration and utilization of all ancillary systems as appropriate.
Highlight issues/risks to delivery by understanding interdependencies. Define mitigations and drive to resolution with cross-functional stakeholders as part of Risk Management Plan.
Review and analyze metrics to derive meaningful summary of study health and trends.
Review of the Master Services Agreement, Service Level Agreement, and/or contract to manage toward sponsor-specific metric targets/Key Performance Indicators.
Host and attend cross-functional meetings. Prepare Meeting Agendas and Minutes, comply to action and decision logs.
Bid Pursuits and Proposals
Prepare for and participate in study or program-level Bid Pursuit preparation meetings.
Portray Parexel's technical and operational expertise and capabilities, and tailor to meet sponsor's specific needs.
Create relevant slides with cross-functional Global Data Operations input as appropriate.
Present with confidence and as a cohesive Parexel team with other functions.
Project Quality Management and Compliance
Ensure compliance to Standard Operating Procedures, ICH/GCP Guidelines.
Maintain inspection-ready Trial Master File.
Identification of quality issues, ensuring they are raised in relevant system and closed according to requirements.
Prepare for and participate in audits and inspections for internal, sponsor, and regulatory agencies.
Drive and implement Corrective/Preventive actions for study, and work toward alignment across Parexel as appropriate. Share lessons learned across multiple projects within a program or therapeutic area.
Project Financial and Resource Management
Ensure appropriate project level resourcing of staff and staff assignments. Identify and request functional staff necessary for the project team.
Regular review and update of DM resources to ensure alignment with contracted budget, project resource forecast, actuals, and demand, utilizing the necessary systems and tools.
Determine and resolve the root cause of DM-related project variance in a timely manner, including negotiating/raising changes in scope.
Company Initiatives
Provide Data Management functional input, considering the impact of the initiative and the impact on Data Management and Parexel as a whole.
Guide and lead other functions as appropriate to provide meaningful functional feedback on the initiative.
Ensure Parexel-requested information entered into management systems is accurate and regularly updated.
Participate in creation/review of SOP process and/or templates - provide input as a Subject Matter Expert (SME) where necessary.
Training
Deliver Project Specific Training to internal DM team as required.
Deliver on-the-job training where needed/requested.
May deliver instructor-led training.
What we are looking for in this role
For every role, we look for professionals who have the determination and courage always to put patient well-being first. That to us is working with heart.
Skills:
Excellent ability to lead and collaborate with global teams. Motivate/guide virtual teams across multiple time zones and cultures to work effectively.
Excellent negotiation skills and ability to influence, in order to achieve mutually beneficial results.
Excellent interpersonal, oral and written communication skills, using concise phrasing tailored for the audience with a diplomatic approach.
Learning ability and knowledge sharing approach; swift understanding of technologies and new processes.
A flexible attitude with respect to work assignments and new learning; ability to adjust rapidly to changing environments.
Advanced presentation skills.
Customer focus to interact professionally and respectfully within Parexel and all external colleagues to build rapport and trust.
Commitment to first-time quality, including a methodical and accurate approach to work activities.
Time management and organizational skills, in order to meet objectives and timelines.
Highly developed problem-solving skills, including capability to make appropriate decisions in ambiguous situations, ability to conduct root cause analyses.
Ability to travel as required.
Written and oral fluency in English.
Knowledge and Experience:
Substantial experience in clinical research industry.
Proven record of leading project and program teams.
Advanced understanding of project tools, reports and processes for management of project financials with regards to forecasting, revenue recognition, scope of work and department budget for assigned projects.
In-depth understanding of Clinical Study Team roles outside of Data Management.
Full understanding and application of relevant ICH-GCP Guidelines, local regulatory requirements and Parexel SOPs and study specific procedures.
Awareness of SDTM/CDISC/CDASH standards.
Advanced technical skills including, but not limited to the knowledge of Clinical Trial/Data Management Systems (e.g. InForm, Rave, Veeva, DataLabs) and Microsoft Office products.
Education:
Bachelor’s degree and/or other medical qualifications or relevant industry experience.
Certification or involvement in a professional society or organization is recommended.
Who are Parexel
Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.
We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.
-
Senior Data Management Lead
3 hours ago
Bloemfontein, Orange Free State, South Africa Parexel Full timeSenior Data Management LeadParexel is seeking a highly skilled Senior Data Management Lead to join our team. As a key member of our Clinical Study Team, you will be responsible for providing leadership and expertise in all aspects of Data Management.Key Responsibilities:Develop and manage timelines for study data deliveries, including Go-Live, Interim...
-
Senior Data Management Lead
3 weeks ago
Bloemfontein, Orange Free State, South Africa IQVIA Full timeAbout the RoleWe are seeking a highly experienced and skilled Senior Data Management Lead to join our team at IQVIA. As a key member of our Data Management team, you will be responsible for leading the delivery of data management services for single/multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction.Key...
-
Senior Data Management Lead
7 days ago
Bloemfontein, Orange Free State, South Africa IQVIA Full timeJob OverviewAs a Senior Data Team Lead at IQVIA, you will be responsible for independently managing end-to-end delivery of data management services for single/multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction.Key ResponsibilitiesProvide comprehensive data management expertise to Clinical Data Management...
-
Senior Data Management Team Lead
3 weeks ago
Bloemfontein, Orange Free State, South Africa IQVIA LLC Full timeAbout the RoleWe are seeking a highly experienced and skilled Senior Data Management Team Lead to join our team at IQVIA LLC. As a Senior Data Management Team Lead, you will be responsible for independently managing end-to-end delivery of data management services for single/multi-service projects, ensuring quality deliverables on time and within budget, to...
-
Senior Data Team Lead
4 months ago
Bloemfontein, South Africa IQVIA Full timeJob Overview Independently manage end-to-end delivery of data management services for single/multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer...
-
Senior Clinical Data Analyst
3 hours ago
Bloemfontein, Orange Free State, South Africa Parexel Full timeJob Title: Senior Clinical Data AnalystParexel is seeking a highly skilled Senior Clinical Data Analyst to join our team. As a Senior Clinical Data Analyst, you will be responsible for leading and coordinating clinical data validation activities on assigned projects, with a high degree of proficiency and autonomy.Key Responsibilities:Lead and/or coordinate...
-
Data Management Lead II
3 hours ago
Bloemfontein, Orange Free State, South Africa Parexel Full timeJob Title: Data Management Lead IIParexel is seeking a highly skilled Data Management Lead II to join our team. As a key member of our clinical data management team, you will be responsible for providing leadership and expertise in all aspects of data management.Key Responsibilities:Develop and manage timelines for study data deliveries, including Go-Live,...
-
Data Management Lead I
3 hours ago
Bloemfontein, Orange Free State, South Africa Parexel Full timeJob Title: Data Management Lead IParexel is seeking a highly skilled Data Management Lead I to join our team. As a Data Management Lead I, you will be responsible for providing leadership in all aspects of Data Management, including managing timelines for study data deliveries, collaborating with cross-functional teams, and ensuring compliance with...
-
Senior Clinical Data Analyst
2 months ago
Bloemfontein, South Africa Parexel Full timeWe have several roles open at both Senior CDA and CDA II Levels within our South African Data Management team!!!Senior Clinical Data Analyst:-The Senior Clinical Data Analyst (SCDA) independently performs/lead and/or coordinate all clinical data validation activities on assigned projects, commensurate with experience and/or project role, with high degree of...
-
Senior Clinical Data Analyst
2 months ago
Bloemfontein, South Africa Parexel Full timeWhen our values align, there's no limit to what we can achieve. We have several roles open at both Senior CDA and CDA II Levels within our South African Data Management team!!! Senior Clinical Data Analyst:- The Senior Clinical Data Analyst (SCDA) independently performs/lead and/or coordinate all clinical data validation activities on assigned...
-
MS Operations Manager
4 months ago
Bloemfontein, South Africa Dimension Data Full timeFunctieomschrijvingThe key function is to retain and support the growth of client portfolios through effective and well managed service delivery. Fulfils the role of a single client touch point and key custodian of relationships both internally and externally, including clients and support teams, for the co-ordination and delivery of services to the client....
-
Senior Clinical Data Analyst
14 hours ago
Bloemfontein, South Africa Parexel Full timeWhen our values align, there's no limit to what we can achieve. Parexel are currently recruiting for a Senior Clinical Data Analyst in South Africa. In this role, the Senior Clinical Data Analyst (SCDA) independently performs/leads and/or coordinates all clinical data validation activities on assigned projects, with a high degree of proficiency and...
-
IT Service Delivery Manager
2 weeks ago
Bloemfontein, Orange Free State, South Africa Dimension Data Full timeJob SummaryWe are seeking a highly skilled IT Service Delivery Manager to join our team at Dimension Data. As a key member of our service delivery team, you will be responsible for retaining and growing client portfolios through effective service delivery.Key ResponsibilitiesAnalyze client portfolios to identify risks to service coordination and report on...
-
Biometrics Delivery Lead
3 weeks ago
Bloemfontein, Orange Free State, South Africa Parexel Full timeAbout the RoleThe Biometrics Delivery Lead is a key position within Parexel, responsible for overseeing the execution of Data Operations strategies and technology setup for EMEA projects. This role requires strong leadership and management skills, with a focus on database programming, data integration, data management, statistical services, and medical...
-
Data Management Lead I
14 hours ago
Bloemfontein, South Africa Parexel Full timeWhen our values align, there's no limit to what we can achieve. Parexel are currently recruiting for a Data Management Lead I in South Africa. In this role, the Data Management Lead l (DML I) provides leadership in all aspects of Data Management. Manages timelines for study data deliveries, including Go-Live, Interim Deliveries, and Final DB Lock....
-
Senior Clinical Data Analyst
3 weeks ago
Bloemfontein, Free State, South Africa myGwork - LGBTQ+ Business Community Full timeThis job is with Parexel, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. We have several roles open at both Senior CDA and CDA II Levels within our South African Data Management team!!!Senior Clinical Data Analyst:-The Senior Clinical Data Analyst...
-
Lead Android Developer
3 weeks ago
Bloemfontein, South Africa OfferZen Full timeSenior Android EngineerAre you a skilled senior Android engineer looking for a challenging role? OfferZen, a leading developer jobs marketplace, connects talented developers with top tech companies that are eager to collaborate.This could be the ideal opportunity for you to leverage your expertise and advance your career. Why waste time applying to multiple...
-
IT Service Delivery Manager
3 hours ago
Bloemfontein, Orange Free State, South Africa Dimension Data Full timeJob Title: MS Operations ManagerJob Summary:The MS Operations Manager is responsible for retaining and supporting the growth of client portfolios through effective and well-managed service delivery. This role serves as a single client touch point and key custodian of relationships both internally and externally, including clients and support teams, for the...
-
Data Management Lead II
15 hours ago
Bloemfontein, South Africa Parexel Full timeWhen our values align, there's no limit to what we can achieve. Parexel are currently recruiting for a Data Management Lead II in South Africa. In this role, the Data Management Lead II (DML II) provides leadership in all aspects of Data Management. Develop and manage timelines for study data deliveries, including Go-Live, Interim Deliveries, and...
-
Biometrics Delivery Lead
3 days ago
Bloemfontein, Orange Free State, South Africa Parexel Full timeJob Title: Biometrics Delivery LeadParexel is seeking a highly skilled Biometrics Delivery Lead to join our team. As a key member of our Global Data Organization, you will be responsible for the execution of the Data Operations strategy and technology setup for EMEA projects.Key Responsibilities:Provide leadership and management for database programming,...