Helena Mostert

- This role is named Senior Clinical Trial Associate under the FSP ICON Plc, and named Contract & Finance Specialist under the Client.

- The Contracting Specialist is accountable for coordination, preparation, and execution of clinical study contracts (Principal Investigator, Site (Health Care Organization), Institution (Health Care Organization), MSA, local vendors, etc., as applicable) in a direct country or extended country group (OPC and satellite countries) in close collaboration with Study Start-Up Managers, Clinical Project Managers and Finance Specialists in compliance with Novartis
processes, GCP/ICH and regulatory requirements.

- The Finance Specialist is accountable for budget planning, analytics and payment execution in a direct country or extended country group (OPC and satellite countries) in close collaboration with the Study
Start-Up Managers, Clinical Project Managers and Contracting Specialists in compliance with Novartis processes, GCP/ICH and regulatory requirements.
- Supports country SSU strategy in close collaboration with the Study Start-Up Team Lead and the Study Start-Up Managers to ensure SSU timelines and deliverables are met according to country commitments.
- Accountable for coordination, preparation, and execution of clinical study contracts and amendments (Principal Investigators, site (Health Care Organizations), institution (Health Care Organizations), MSA, local vendors, etc., as applicable) for assigned projects.
- Tracks and oversees contract status including the dispatch and return of contracts and ensure execution and filing of same, once executed.
- Negotiates financial & legal conditions, escalates issues as applicable.
- Single point of contact for local Legal and ERC (e.g., for patient reimbursement topics).
- Develops and standardizes local contract templates (e.g., for EC submission if required by local regulation) and MSAs.
- Adheres to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements.
- Implements innovative and efficient processes which are aligned with Novartis strategy.
- Supports country SSU strategy in close collaboration with Study Start-Up Team Lead and Study Start-Up Managers to ensure SSU timelines and deliverables are met according to country commitments.
- Responsible for accounting and execution of investigator payments in a direct country or extended study group (OPC and satellite countries) in close collaboration with Study Start-Up Manager, Clinical Project Manager and Contracting Specialist in assigned projects.
- Project controlling & budget management supports financial planning, forecasting and management, analyses, and reports project costs and their drivers.
- Set-up & validation of investigator contracts in the accounting system for clinical studies.
- Executes and monitors internal controls.
- Translates Grant Plans into local Payment Schemes.
- Prepares and submits country TCF(s).
- Updates systems (ACT, Optimus, etc.).
- Executes payments, communicates with sites when it comes to payment issues.
- Tracks and oversees payment status.
- Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements.
- Implements innovative and efficient processes which are in line with Novartis strategies.

- Cultivates productive working relationships with key opinion leaders in the field to enhance scientific credibility and promote trial awareness among stakeholders.

- Supported the successful completion of all study milestones by proactively identifying potential challenges and implementing well-coordinated action plans to address them.

- Reduced study timelines by effectively coordinating efforts between cross-functional teams and external vendors.

I dedicated time to focusing on my personal wellness and seeking a role that aligned better with my professional aspirations and capabilities. At IQVIA, I found that my skill set was underutilized, and I desired a position that offered greater responsibilities and allowed me to fully leverage my expertise and potential.

- Review Requests For Proposal (RFP).

- Identify information for proposal
text and budget development and work closely with proposal development team to prepare and finalize proposals.
- Provide support and expertise to other Proposal Developers in the delivery of assigned opportunities.
- Revise or develop preliminary agreements and related budgets and scope of work. Ensure the scope of work is defined correctly and budgets reflect the scope.
- Develop in depth understanding of and be compliant to all processes and policies relating to the development of proposals.
- Participate in strategy calls to discuss customer requirements and identify discrepancies in customer information.
- Perform quality control edits on all documents and participate in the finalization of documents and distribution to the customer and internal
departments.

- Update and maintain corporate databases as required and ensure accurate information is included in tracking reports.
- May participate in training / coaching / mentoring new staff.
- Deep understanding of protocol is required, along with ability to transfer the scientific information of the protocol and the SOE onto the budget to
produce an RNPS budget (Remote Nursing and Phlebotomy Services).
- May participate in customer meetings.
- Participates in department initiatives.
- Perform all other duties as assigned.

- Self-motivated, with a strong sense of personal responsibility.

- Excellent communication skills, both verbal and written.

- Proven ability to learn quickly and adapt to new situations.

- Skilled at working independently and collaboratively in a team environment.

- Monitored incoming contracts and service agreements for correct pricing and information.

- Created solicitation packages and conducted thorough research for each bid.

- Assessed risks inherent in contract changes and potential impacts, informing management in detail of concerns to avoid liabilities.

- Independently managed a high volume of contracts across a range of sizes, from large, complex agreements to smaller, standard contracts, ensuring compliance with expected turnaround times and operating with minimal supervision.

- Proficiently drafted and reviewed legal and business contract terms, adhering to the organization's contract playbook and seeking attorney guidance when necessary to address complex matters.

- Acted as the primary point of contact for the review and negotiation of both standard and non-standard contracts, seamlessly coordinating with Legal, Finance, and various internal teams to accommodate changes and expedite the execution of mutually agreeable contracts.

- Acquired comprehensive knowledge of IQVIA’s U.S. Business Line and its various service lines and product offerings, achieved through on-the-job contract engagement and continuous formal and informal learning opportunities.

- Prepared client-facing deliverables such as statements of work, amendments, and other correspondence, while identifying and mitigating potential risks in contract terms and conditions to protect the organization’s interests.

- Effectively articulated and communicated concerns to relevant legal and business representatives within IQVIA, ensuring clarity and alignment.

- Utilized strong business acumen to propose solutions addressing client concerns in alignment with organizational objectives, ensuring mutually beneficial outcomes.

- Contributed to process improvements by identifying and implementing contracting efficiencies, often in collaboration with internal teams and stakeholders, fostering operational excellence and streamlined workflows.

- Reviewed contract plans and project specifics for thorough understanding.

- Negotiated optimal contract terms and conditions to lessen business risk and maximize financial objectives.

- Maintained digital and paper and contractual files, ensuring compliance with regulatory mandates and company policies.

- Mitigated legal risks by conducting thorough reviews of contractual agreements before finalizing negotiations.

- Assumed overall management responsibility for the end-to-end contract process for diverse accounts, ensuring seamless coordination with Operations, Project Management, Legal, Business Development, and Finance teams to prepare, review, and negotiate contracts effectively.

- Served as the primary point of contact for clients during contract negotiations, fostering collaborative relationships and ensuring clear communication throughout the negotiation phase.

- Maintained ongoing interface with clients regarding contractual matters throughout the lifecycle of projects, ensuring alignment and prompt resolution of issues.

- Established and sustained direct client relationships, demonstrating exceptional client management and engagement skills.

- Created, negotiated, and finalized a wide array of contractual documents, including budgets, Start-Up Agreements, Work Orders, and Change Orders, ensuring alignment with organizational and client expectations.

- Developed account-specific standards for contracts, including presentation formats for budgets, payment terms, and standard contractual language, facilitating discussions and negotiations with clients as necessary.

Proactively collaborated with project management teams to monitor project status, reviewed contractual compliance, identified scope changes, and ensured adherence to milestones outlined in agreements.

- Worked closely with Finance to manage ongoing budget changes, providing finance-system-ready budget tools while adhering to organizational policies and procedures.

- Ensured all contractual documents and related information were accurately processed and maintained within relevant databases, ensuring organizational data integrity.

- Customized company contract templates to meet unique client requirements, balancing standardization with tailored client needs.

- Actively participated in the development and testing of tools and procedures to enhance departmental efficiency and adaptability.

- Held comprehensive management responsibility for overseeing the contract process across a range of accounts, effectively coordinating with key teams, including Operations, Project Management, Legal, Business Development, and Finance, to facilitate the preparation, review, and negotiation of contracts.

- Acted as the primary client contact throughout the negotiation phase, ensuring seamless communication and fostering collaborative relationships.

- Maintained consistent and proactive engagement with clients to address contractual issues across the lifecycle of projects, reinforcing trust and ensuring alignment on project objectives.

- Established and nurtured direct client relationships to strengthen long-term partnerships.

- Led the creation, negotiation, and finalization of comprehensive contractual documents, such as budgets, Start-Up Agreements, Work Orders, and Change Orders, ensuring precision and alignment with both client expectations and organizational standards.

- Developed tailored account-specific standards for contracts, including customized budgets, payment terms, and contract language, facilitating successful negotiations with clients.

- Proactively engaged with project management teams to monitor project progress, ensure compliance with contractual terms and milestones, and identify and address scope changes in a timely manner.

- Worked closely with Finance to manage and reconcile budget adjustments, delivering finance-system-ready budget tools and maintaining compliance with relevant organizational policies and procedures.

- Ensured all contractual data and documents were accurately processed, managed, and maintained within centralized databases, promoting accuracy and transparency.

- Modified company templates to align with specific client requirements while maintaining consistency with organizational policies.

- Contributed to the evolution and refinement of operational tools and procedures by participating in their development and testing, thereby supporting continuous improvement and process efficiency.

- Negotiated optimal contract terms and conditions to lessen business risk and maximize financial objectives.

- Mitigated legal risks by conducting thorough reviews of contractual agreements before finalizing negotiations.

- Reviewed contract plans and project specifics for thorough understanding.

- Achieved successful dispute resolutions through active listening and empathetic communication skills.

- Coordinated closely with other departments within the organization for seamless collaboration during multifaceted dispute resolutions, ensuring all relevant parties were informed and engaged throughout the process.

- Managed high caseloads, ensuring timely resolution of conflicts and promoting client satisfaction.

- Developed customized mediation plans to address unique client needs and facilitate fair outcomes.

- Presided over disciplinary and incapacity hearings with fairness and adherence to procedural standards, ensuring compliance with relevant employment laws and guidelines.

- Managed grievance processes with sensitivity and impartiality, fostering an environment of transparency and resolution.

- Provided support during operational requirement termination procedures, ensuring legal compliance while balancing business objectives and employee dignity.

- Represented members during external dispute resolutions at key forums, including the Motor Industry Bargaining Council (MIBCO) Dispute Resolution Centre (DRC), the Commission for Conciliation, Mediation, and Arbitration (CCMA), and the Labour Court.

- Actively advocated for members' interests while upholding integrity and the principles of labor law.

- Delivered comprehensive industrial relations support through case reviews, offering strategic and legally aligned advice to both employers and employees.

- Drafted employment contracts with precision to ensure clarity, compliance, and alignment with labor regulations.

- Offered counsel on a wide range of industrial relations matters, including but not limited to:

- Disciplinary Inquiries: Provided guidance on conducting procedurally fair and legally compliant disciplinary processes.

- Retrenchments: Assisted in ensuring retrenchment exercises followed regulatory requirements while mitigating risk and maintaining organizational integrity.

- Managing Poor Work Performance: Provided advice on formal performance improvement plans and constructive feedback mechanisms to address underperformance in accordance with labor guidelines.

- Medical Incapacity: Facilitated fair and empathetic assessment processes regarding medical incapacity matters, ensuring compliance with employment laws and the principles of human dignity.

- Grievance Handling: Assisted in resolving employee grievances through structured and impartial processes designed to address concerns effectively and equitably.

- Union Negotiations: Supported and mediated negotiations with labor unions to achieve mutually acceptable outcomes that balanced employee satisfaction with organizational objectives.

- In all areas, ensured best practices while prioritizing constructive relationships and compliance with labor legislations, fostering an environment of respect, fairness, and productivity.

I took the opportunity to thoughtfully re-evaluate my career aspirations and the type of work that would bring both professional fulfillment and meaningful impact. This reflection led me to intentionally seek a role where I could contribute holistically, making a significant difference to the organization, its stakeholders, and the broader community.

- Managed employee relations issues professionally, resolving conflicts efficiently while maintaining confidentiality at all times.

- Monitored and handled employee claims involving performance-based and harassment incidents.

- Facilitated open communication channels between employees and management by conducting regular town hall meetings or roundtable discussions.

- Collaborated with executive leadership to align HR initiatives with overall business goals and objectives.

- Chaired and presided over all disciplinary hearings with professionalism, ensuring the process upheld procedural fairness and adhered to applicable labor laws. Compiled comprehensive and accurate findings reports, supporting decisions for dismissals or issuing formal warnings.

- Represented the organization during dispute resolution proceedings at the Commission for Conciliation, Mediation, and Arbitration (CCMA) and the Bargaining Council. Actively advocated for the company in matters referred after dismissal decisions made during hearings conducted under my chairmanship.

- Observed and evaluated the application of Polygraph Testing as an additional evidentiary method in the context of disciplinary hearings, ensuring the testing adhered to ethical and procedural guidelines while aligning with organizational policies.

- Witnessed and assessed the use of Alcohol Testing as a verification method in misconduct cases involving workplace intoxication, ensuring the process supported disciplinary recommendations and was applied objectively.

- Gained direct exposure to labor unrest by observing an active labor strike, managed effectively by Labor Net. This experience deepened my understanding of collective labor dynamics, strike resolution strategies, and stakeholder management during industrial actions.

- Drafted written warnings in response to managerial directives, ensuring they reflected accurate and legally compliant documentation of employee misconduct issues. Subsequently, I served and communicated these warnings to employees with clarity, maintaining a professional approach to uphold workplace accountability.

- Through these activities, I demonstrated an ability to navigate the intricacies of industrial relations, disciplinary processes, and employee advocacy, while fostering compliance, transparency, and fairness within the organization.

- Collaborated with executive leadership to align HR initiatives with overall business goals and objectives.

- Facilitated onboarding sessions and on-the-job training for new hires, bolstering employee job position knowledge and skillset.

- Maintained accurate HR records in compliance with applicable laws, ensuring efficient data retrieval when required.

- Motivated employees through special events, incentive programs, and constructive feedback.

- Implemented customized performance management systems, providing ongoing feedback and development opportunities for employees.

- Consistently met or exceeded performance goals set by management, demonstrating commitment to excellence within the role of Claims Assessor.

- Effectively managed high-pressure situations during peak periods of claims activity while maintaining professional demeanor and efficient performance levels.

- Reduced turnaround time for claim settlements by prioritizing tasks, effectively managing caseloads, and collaborating with cross-functional teams.

- Participated in regular meetings with other departments to provide insights on emerging trends in claims activity, influencing strategic decision-making processes within the organization.

- Actively liaised with attorneys on matters related to accounts, member inquiries, and claim-related queries, ensuring prompt and effective resolution of issues while maintaining clear lines of communication. This involved providing necessary documentation, clarifying complex scenarios, and identifying solutions aligned with organizational policies and legal frameworks.

- Managed the taxation of accounts by thoroughly reviewing account details, ensuring accuracy, and adhering to applicable regulations. This process demonstrated a meticulous approach to financial management and compliance.

- Conducted comprehensive assessments of claims, performing detailed evaluations to determine their validity in accordance with policy guidelines. Where applicable, professionally issued repudiations of claims with supporting evidence and rationale, ensuring policyholder understanding while minimizing disputes.

- Provided policy coverage determinations by interpreting the terms and conditions of insurance policies, ensuring that policyholders received clear and accurate information regarding their entitlements and exclusions. This involved balancing business objectives with a commitment to ethical practices and customer care.

- Drafted well-structured and professional correspondence directed to attorneys and policyholders, including explanatory letters, claim updates, and other requisite communications. Each letter was crafted with clarity, empathy, and professionalism, ensuring alignment with both legal standards and organizational tone.

- These responsibilities required a high degree of attention to detail, excellent communication skills, and a thorough understanding of legal, policy, and financial principles, enabling effective support for all stakeholders involved.

- Managed high-profile cases with attention to detail and strategic planning, resulting in successful resolution or settlement.

- Assisted in developing new business opportunities through participation in networking events and fostering relationships within the industry.

- Achieved favorable outcomes for clients by skillfully drafting and negotiating complex contracts, agreements, and settlements.

- Represented clients before administrative agencies or tribunals, advocating effectively on their behalf for desired outcomes.

- Represented clients in both criminal and labor-related legal matters, directly arguing their cases in court without the assistance of an advocate. This demonstrated strong legal acumen, confidence, and a nuanced understanding of procedural and substantive law across both domains.

- Conducted in-depth consultations with clients to understand their circumstances, develop case strategies, and provide informed legal advice. Emphasized empathetic communication to build trust and ensure clients were fully apprised of their legal positions and potential outcomes.

- Negotiated fees with clients in a fair and transparent manner, balancing their financial capacities with the value of legal services provided. This included tailoring fee arrangements to support accessibility while ensuring alignment with professional standards.

- Prepared and drafted detailed and accurate accounts for clients as well as the organizations the firm partnered with or rendered services to. These accounts reflected an understanding of legal and professional billing practices, ensuring clarity and precision in the conveyance of services rendered.

- Assisted with the preparation and consultation of clients involved in Road Accident Fund (RAF) matters under the supervision and guidance of Mr. Leon Theron, a Director at the firm. Responsibilities included drafting necessary documentation, evaluating claim submissions, advising clients on legal procedures, and guiding them through the claims process while safeguarding their best interests.

- This combination of responsibilities showcases expertise in independent case management, legal representation, fee negotiations, and meticulous client service, reflecting a well-rounded and client-centered approach to legal practice.

- Streamlined the trial preparation process for senior attorneys, resulting in more efficient case management.

- Organized client files meticulously, maintaining confidentiality while ensuring easy access to vital information for team members.

- Contributed positively to firm culture by participating in networking events, pro bono activities, and professional development opportunities.

- Drafted clear and concise motions, briefs, and other legal documents that effectively conveyed the client''s position to the court or opposing counsel.

Independently represented clients in criminal defense cases, handling bail applications and trials in Magistrate Court without senior or advocate support, including conducting thorough research and trial preparation for complex matters.

- Advocated for clients in labor disputes at the CCMA, representing both employers and employees.

- Managed client consultations, negotiated fees, and prepared accounts and correspondence.

- Drafted summons and pleadings, while preparing for and presenting arguments in civil in limine proceedings in Court.

-Conducted thorough research on various areas of law, ensuring accurate information and strong case foundations.

-Prepared essential legal documents for successful case outcomes and settlements.

-Managed multiple caseloads simultaneously without compromising quality or timeliness of work product.

-Kept abreast of developments in relevant legislation, ensuring that advice given was current and accurate at all times.

- Conducted independent court appearances in Magistrate's Court for accused persons without Director or Advocate support.

- Assisted and gained experience by shadowing Directors in criminal, labor, and civil matters.

- Drafted client accounts and handled legal work for organizations such as Legal Wise, Scorpion, Clientele, and Legal Aid.

- Prepared and managed correspondence on behalf of clients and partner organizations.

- Managed consultations and the legal process for Road Accident Fund cases under the supervision of Principal, Mr. Leon Theron.