Optential Consulting
2 weeks ago
Strategic Association Director
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Company information
- Company
- Optential Consulting
- Location
- South Africa South Africa
- Posted
- 2 weeks ago
Job description
Bloemfontein, South Africa
Bellville, South Africa
Centurion, South Africa
Full time
R
Manage end-to-end delivery of data management services for single/multi-service projects with minimal guidance, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Data Management (DM) team to provide high quality data management products that meet customer needs. Provide leadership to the team in the areas of project planning, execution, and close-out; overview of financial management for data management activities; communications; and milestone deliverables. Perform role of Data Team Lead (DTL).
Essential Functions- Gather Study Set up requirements through discussion and communication with relevant stakeholders.
- With Minimal guidance - support, overview of validation of new Device integrations.
- Oversight & perform regular Data cleaning activities to ensure clean data with quality and timely deliverables to sponsor.
- Ensure that all the deliverables are of expected quality standards and meet customer expectations.
- With guidance, ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW).
- Support Training of New joiners.
- Lead internal study meetings and internal/sponsor audits and participate in Study Kick off meetings and other sponsor meetings.
- Tracks and manages the projects, oversees project progress, identifies risks and takes corrective action to rectify any errors as recommended as required.
- With Guidance manage & oversight the implementation of new technology / database revisions.
- Work closely with the programming team for process innovation and automation.
- Be compliant to trainings and eSOP reading.
- Provide review and expert opinion in developing, revising, and maintaining core operating procedures and working instructions.
- Communication with Line Manager, and other team members across functions should be collaborative.
- Perform other duties as directed by Line Manager.
- Bachelor's Degree In health, clinical, biological or mathematical sciences, or related field with proven experience in Data Management Req
- 3 -4 years direct Data Management experience, including a minimum of 1 year as a CDM project lead. Pref
- English Fluency Spoken and English Advanced
- Advanced computer applications like Microsoft excel, word, Inbox etc Advanced
- Should have Advanced understanding of Drug development lifecycle and Overall Clinical research process Advanced
- Lead data management for complex, global clinical trials from study setup to database lock.
- Serve as the main client contact for all data management deliverables.
- Oversee SAE, PK, and external data reconciliation and database deployment.
- Manage timelines, budgets, and resource allocation to meet customer expectations.
- Mentor junior data management staff and promote best practices.
- Drive process improvements and ensure regulatory and SOP compliance.
- Bachelor's degree in life sciences, health, clinical, biological, or mathematical field.
- No less than 10 years of direct clinical data management experience, with 5+ years in a Lead Clinical Data Management role.
- Your previous roles/job titles may include Clinical Data Manager, Senior Clinical Data Manager, Lead Data Manager, Principal Data Manager, and/or Data Management Project Manager.
- Proven success managing large global studies (1000+ patients).
- Expertise with Medidata Rave, Oracle InForm, or similar EDC systems.
- Strong understanding of GCP, ICH, and clinical research processes.
- Excellent communication and leadership skills.
- Fully remote role - company equipment provided
- Competitive salary and performance-based incentives
- Career growth and learning opportunities through mentoring and internal mobility
- Inclusive, global culture focused on innovation and collaboration
- Recruiter video chat (20 min)
- Hiring manager interview (1 hour, MS Teams - Offer decisions are typically made within one or two weeks of the final interview.)
EEO Minorities/Females/Protected Veterans/Disabled
Required skills
- mentoring
- project management
- quality standards
- competitive salary
- automation
- collaboration
- risk management
- innovation
- leadership skills
- inclusive culture
- gcp
- data management
- best practices
- regulatory compliance
- resource allocation
- microsoft word
- ich
- career growth
- clinical trials
- eeo
- microsoft excel
- learning opportunities
- process innovation
- process improvements
- ms teams
- life sciences
- client contact
- english fluency
- clinical research
- health sciences
- sop compliance
- working instructions
- data cleaning
- remote role
- sow
- operating procedures
- performance incentives
- esop
- biological sciences
- internal mobility
- lead data manager
- drug development
- scope of work
- external data reconciliation
- sae reconciliation
- clinical sciences
- mathematical sciences
- global culture
- company equipment
- edc systems
- medidata rave
- oracle inform
- hiring manager interview
- database lock
- clinical data manager
- global studies
- database deployment
- study kick off
- database revision
- cdm project lead
- pk reconciliation
- lead clinical data management
- senior clinical data manager
- principal data manager
- data management project manager
- recruiter video chat
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