Latest Jobs at Covance

About the job

The Lead EDC RAVE designer will be remotely located anywhere South Africa.

• Protocol interpretation skills (someone with data management skills)
• Technical expertise : Design Screens in Rave
• Technical expertise : Program edits in Rave
• Individual Project oversight role
• Project management/oversight across inter and intra teams.
• Limited sponsor interaction at individual study communication ( wrt protocol and/or Rave technicalities)

Education:

• University/college degree (life science, computer science, programming, pharmacy or related subject preferred), or certification in a related profession from an appropriately accredited institution (e.g., nursing certification, computer science, medical or laboratory technology)
• Good knowledge of drug development process and Clinical Data Management Programming.
• Good knowledge of relational database.
• Fluent in English, both written and verbal

Experience:

• Previous relevant work experience to include data management and database support: EDC systems programming or SAS programming.
• Medidata RAVE and protocol interpretation experience strongly preferred.
• Good problem solving skills and a proactive approach.
• Good oral and written communication skills.
• Good knowledge of clinical trial process and data management, biometrics, and systems applications to support operations preferred.
• Ability to work in a team environment.
• Ability to work effectively under minimal supervision.
• Ability to prioritize work.
• Ability to mentor and train the team members.
• Good time management skills and the ability to work to tight deadlines whilst maintain the highest standards of quality work.
• A cooperative and team oriented approach.

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About the job

Covance by Labcorp is looking for an Associate External Data Specialist Portfolio Lead homebased in EMEA.

Duties:

• Lead for studies which are highly complex including but not limited to combination of healthy volunteer and patient populations, multi-site, complex protocol design, strong client management required or reduced timelines.
• As the study data lead/Client programme lead; 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
• Ensure that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of
• 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 ECD 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
• Maintain awareness of other Biometrics functional group deliverables to be able to support risk and mitigation strategies, including impact on Data Management resources or deliverables and consult with Project Manager and/or functional group management as
• Keep Project Manager, Biometrics management team and/or sponsor services informed of pertinent project or sponsor related information (i.e. budget status, work scope changes, timeline impacts).
• Coordinates the receipt and inventory of all data related information, from clinical sites and vendors as appropriate in order to meet timelines for deliverables. Ensure all appropriate documentation and procedures are performed upon project
• Develop and maintain client relationships and review client satisfaction surveys. Implement appropriate action plans including driving process improvements and team
• Applies corrective interventions where necessary to maintain project budget compliance and profit expectations. Track scope changes and work with the Clinical Pharmacology Project Manager to ensure that Sponsor approval is received and the scope change
• Provides leadership, mentorship, and coaching in DM related clinical trial processes, department technical capabilities, and associated turnaround
• Coordinates with the DM Global Trainer and DM technology SMEs to coach and mentor study members on DM technologies and best practices for DM applications/tasks such as (EDC execution, SOP forms completion, tracking tools, reviewing vendor data in SAS Viewer, data listings creation, data cleaning).
• Provide support to Data Management supervisors and managers on the performance evaluation of other team members, provide constructive feedback to aid in career development, interpersonal skills and achievement of competency
• Accountable for learning new DM technologies and applied processes, keeping up-to-date with industry wide technology and feasibility for process improvement at Covance
• Ensures service and quality meet agreed upon specifications per the DMP and scope of
• Have input in writing, reviewing and updating SOPs and associated documents as
• Maintain accurate records of all work
• Perform reconciliation of the clinical database against safety data, laboratory data or any other third party data as appropriate. Utilise local laboratory systems and batch data load facilities where appropriate.
• Represent Data Management and where necessary overall Biometrics in new business
• Attend and action client or internal audits as appropriate and resolve all issues within an appropriate Address client comments with the study team.
• Works with management team to develop and implement directional strategy by providing technical input into discussions, and rolling out training/mentorship to DM staff as
• Actively promote Biometrics services to sponsors whenever
• Performs other related duties as assigned by management

Qualifications and Experience:

• University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
• Previous DM experience with direct sponsor management and at least 2 years technical mentoring experience. Proven experience in handling customer negotiations and experience with managing Scope of Work and budgets.
• Thorough knowledge of clinical trial process, DM, clinical operations, biometrics, and system applications to support
• Proven ability to lead by example on project strategies and achievement of department goals, objectives and initiatives and to encourage team members to seek
• Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical/biotechnological companies.
• Time management skill and ability to adhere to project productivity metrics and timelines
• Ability to work in a team environment and collaborate with peers
• Ability to mentor junior members of the department, providing SME guidance on Data Management practices
• Experience of representing Data Management in bid defense meetings, providing innovative solutions to meet client
• Good organizational ability, communication and interpersonal skills
• Team working skills and good collaborator skills
• Constructive problem solving attitude while deadline focused with time demands, incomplete information or unexpected events.

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About the job

Covance by Labcorp is looking for a SAS Programmer homebased in South Africa.

• Expected to assist with leading EDC Builds and mentor the study team in setting up Medidata RAVE, Oracle Inform, or SAS or any other proprietary software.
• Oversees the project work of technical and design staff.
• Manage projects within the scope of assigned budgets.
• Notify project leadership of requests for out-of-scope work and advise management of changes in scope of projects to enable the timely development of change orders.
• Mentor and aide in staff development, and achievement of competency standards
• Assist in the development and implementation of solutions to global technical service issues and concerns regarding Medidata RAVE, and Oracle Inform, or SAS or any other proprietary software, including proactive prevention strategies
• Assist in development of global technical services competency models
• Assist with the development of training programs to ensure staff, project and technical, achievement of position competencies. Present training programs to the technical staff regarding study build, change control and/or CRF Design or SAS reports, listings, Reconciliation reports.
• Participate in the development of global, harmonized SOPs and specific quality work instruction for technical service group activities
• Provide support and trouble-shooting of EDC/SAS and act as the study team liaison.
• Complete assigned work utilizing Medidata RAVE or Oracle InForm or SAS or any other proprietary software according to Covance SOPs, Work Instructions ,and project specific guidelines in accordance with Good Clinical Practices
• Set up EDC DB, program derivations, edit checks, custom functions, SAS checks, listings, reconciliation reports and any post production changes either in EDC or SAS as per business requirements.
• With assistance meet with data manager on assigned projects to discuss technical strategies, contractual obligations and timelines. Escalate resource needs as appropriate.
• Provide consultation in the area of database design and development with data managers.
• Participate in the ongoing review of the processes used by the Acquisition Configuration Implementation and Standards Group to ensure adaptation of best practices.
• Prioritize personal workload to meet specified completion dates and perform work without direction.
• Conduct Peer Review/ Quality Control of study design for assigned projects.
• Review and approve derivation and edit checks requested by the project teams. Discuss alternative programming for procedures, if appropriate.
• Program, test, and maintain derivation and edit check procedures in the EDC environments or SAS programming.
• For EDC systems/SAS, program integrated and associated components as assigned.
• Assist in developing and maintaining data loading procedures.
• Provide feedback to management if any action is needed to increase utilization, improve efficiency or amend the resource levels required on a project.
• Participate in the evaluation and validation of new or updates to software.
• Assume leadership on EDC, SAS sub-team committees. Participate/Lead local User Groups.
• Provide expert technical guidance to project teams, external clients and internal clients within a global setting.
• Prepare and provide internal training on advanced topics as needed in conjunction with senior management.
• Implement processes as they are refined or as new processes are developed and initiate and participate in the ongoing review of the processes to ensure they are continually improved.
• Provide feedback to management on the development potential of staff to assist in staff development.
• Maintain awareness of new developments in EDC or SAS products which may be applied to improve the efficient use of these systems.
• Perform all work with knowledge of regulations pertaining to computerized systems to projects to ensure compliance.
• Perform other duties as assigned.

Education:

• University/college degree (life science, computer science, programming, pharmacy or related subject preferred), or certification in a related profession from an appropriately accredited institution (e.g., nursing certification, computer science, medical or laboratory technology)
• Broad knowledge of drug development process
• Basic knowledge of budgets and relationship to productivity targets
• Thorough knowledge of Medidata RAVE, Oracle Inform, SAS
• Working knowledge of CRF Design and SAS programming
• Working knowledge of System Life Cycle in relationship to the implementation new applications
• Fluent in English, both written and verbal

Experience:

• Previous relevant work experience to include data management and database support: EDC systems programming or SAS programming.
• Demonstrate excellent problem solving skills, a proactive approach and the ability to make sound decisions.
• Demonstrated skill in leading teams, by example and mentoring staff
• Excellent oral and written communication and presentation skills
• Knowledge of clinical trial process and data management, CRF Design, SAS programming and systems applications to support operations
• Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies
• Demonstrated ability to work in a team environment
• Demonstrated ability to handle multiple competing priorities
• Proven managerial and interpersonal skills.