Job Description

South Africa - RemoteAre you ready for the Most Impactful Work of Your Life?Signant Health is a global evidence-generation company. Were helping our customers digitally enable their clinical trial programs, meeting patients where they are, driving change through technology and innovations, and reimagining the path to proof.Working at Signant Health puts you in the very heart of the worlds most exciting sector - a high-growth, dynamic company in an extraordinary industry.Where do you fit in?As part of our team, your Key Accountabilities:

• Communicates effectively within a multi-disciplinary project team to complete assigned tasks on time and within budget.
• Collaborates across functional groups to address technical issues impacting quality/efficiency and drives technical initiatives within Data Management
• Provides data management guidance and communicates with internal and external stakeholders on all aspects of data management activities.
• Authors and updates data management documents (DMP, DTS, CCG. etc.).
• Performs UAT on eCRFs, Reports and Edit Checks programmed to support the data review/cleaning activities specified in the DMP.
• Regularly reviews and follows up on edit checks/data monitoring outputs and verifies data extracts against the DTS, as applicable.
• Facilitates and verifies data clarifications, data corrections, and external data reconciliation with external (customer, CRA, site) and/or internal stakeholders.
• Contributes to process improvements that increase efficiency/quality, mitigate operations risks, improve team performance, and meet departmental objectives and corporate objectives.
• Assists in developing and improving Standard Operating Procedures (SOPs), Working Instructions, and Best Practices.
• Serve as a Data Management SME for Regulatory inspections/audits, Commercial activity (bid defense), and Product (new/updated product features).

Youll need to bring:-

• BA/BS degree in a relevant field (Medicine, Statistics, Computer Science) or equivalent work experience; Certification in CDM.
• 12+ years of professional experience in the clinical trials data management field
• Strong communication (verbal, written) and collaboration skills across technical and non-technical cross-functional stakeholders.
• Ability to complete high quality technical documentation and to understand requirements related to system and front-end functionality, including data process flow.
• Demonstrates extreme attention to detail and organization in all aspects of work.
• Strong ability to problem-solve, and quickly learn and apply new skills, procedures and approaches.
• Demonstrates ability to handle multiple competing priorities, meet deadlines and multi-task in an extremely fast-paced work environment with minimal direct supervision.
• Proven ability to work both independently and in a team-oriented environment, providing support to team members & establishing/maintaining effective work relationships with co-workers within and across functional areas.
• Demonstrates proactive and positive approach to tasks and projects overall, as well as adapting to the types of scheduling & process changes that are inherent in a fast-paced business.
• In-depth knowledge of CDISC standards and clinical trial systems/tools such as eCOA (ePRO, eClinRO), RTSM, EDC, CTMS, CDMS.
• Knowledge of database structures or programming languages such as SAS, SQL, etc.

We would be thrilled if you bring in the below

• Familiarity with GCP and 21 CFR Part 11 is a plus
• Good people/team management skills (direct or indirect supervision)

Decision-Making AND Influence

• Participates in special data-related projects as needed
• Assist with other departmental initiatives and projects as required
• Mentors less experience staff. Ensure project staff are trained and adhere to project-specific, global, standardized data management processes.
• Represent Clinical Data Management in client visits, audits, inspections and bid defenses as needed.

And finally, here are the ways of working that will help you succeed at Signant:

• You have a constructive can-do attitude and can adapt quickly to change.
• Youre motivated by working in a fast-growing global company.
• Youre self-driven and active and continuously want to learn new things.

We know that everyone has different wants and needs, which is why, along with a highly competitive base salary, we support our people and their loved ones with a variety of perks and benefits.As part of our team, some of the benefits you can expect to receive are:

• Our Long Term Incentive Plan, which is unique to the industry
• The flexibility to work remotely
• Medical Aid Contribution
• Pension Contribution

Does this sound like something youd like to explore? Then wed love to hear from you!Please apply below.
We review and respond to every application; keep an eye on your inbox for our reply.Please note that Signant does not accept unsolicited resumes from third-party vendors.#LI-SA1#LI-REMOTEAt Signant Health, accepting difference isnt enough we celebrate it, we support it, and we nurture it for the benefit of our team members, our clients and our community. Signant Health is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or veteran status.

Signant Health