Lilian Nyamwaro
West Berkshire
Summary
A highly skilled and experienced legal professional with great organisational, planning and management skills. I have great interpersonal skills, an excellent team player and always keen to learn and develop new skills. I always take a calm and well thought out approach to problem solving. I have developed a great grasp of governance and core structural, risk and legal provisions pertinent to biopharma industry. I have the ability to prioritise work, account for risk and maintain a high level of accuracy in a fast-paced environment. My skills along with a strong sense of professional integrity contribute significantly towards my achievements. I am a fast learner and always adapt well to new working environments. My previous employment and experience have enabled me to develop good research, analytical and writing skills.
Overview
26
26
years of professional experience
9
9
years of post-secondary education
Work history
Associate Director, Clinical Site Contracts (International)
Vertex Pharmaceuticals
2003.07 - 2026.02
- Responsible for providing oversight to the Site Contracting group in International and ensuring that the goals and objectives of the department are met. Accountable for delivery of Global Site Contract negotiations in support of clinical programs, non-clinical programs, confidentiality agreements and letter of agreements across all therapeutic areas.
- Led Site Contracting group, ensuring effective team performance and compliance with objectives.
- Recommended and guided site contracting strategies, enhancing negotiation outcomes and streamlining processes
- Provide advanced technical knowledge related to global clinical agreements including Fair Market Value assessments and industry standards
- Oversaw resource forecasting and assignments, optimising workload distribution within Site Contracting group
- Oversee site contracting managers and/or therapeutic area leads
- Collaborate with cross-functional teams to drive results
- Identify, develop and ensure delivery of appropriate training for the Site Contracting group
- Communicated regularly with FSP and CRO management to align project goals and expectations.
- Manage quality events and process issues identified in the site contracting group
- Collaborate with Clinical Budget Analyst manager and Site Payment manager to ensure alignment and efficiencies within Clinical Budget Management are maintained
- Managed financial accountabilities and human resource responsibilities for assigned staff within the organisation.
Regional Site Contracting Manager (International)
2020.06 - 2023.06
- Functional Oversight for a team of 14 FSP Site Contracting Representatives in International. Work closely with our FSP partner in managing resourcing needs for our team.
- Close collaboration with cross function team members to discuss and align corporate objectives for all new and maintenance studies.
- Attend leadership calls with COPL/COSL/GCOLT as requested by Head of Site Contracting and participate in ROW study timelines and activation discussions.
- Review and resolve complex Budget Escalations in International and ensure consistency in contracting terms and rates across International.
- Ensure alignment of contracting processes and approach and attend CTAC site selection calls for International.
- Advise all cross-function stakeholders International Site Contracting Timelines in study planning.
- Liaise with legal counsel to resolve any legal issues/queries coming from sites on contracts.
- Manage and continuous contribution to Site Contracting country knowledge database for International.
- Ensure site contracting repositories are updated and maintained to reflect current practices.
- Ensure site contracting reps are providing clear and timely status updates on COMPASS for all their studies.
- Lead regional team meetings.
- Routinely provide Head of Site Contracting updates on issues and escalations in International.
REGIONAL SITE CONTRACTING MANAGER, Clinical Budget Management on assignment with Vertex
Vertex
2019.09 - 2020.06
- Managing Clinical Trial Agreements and Negotiations across multiple studies
- Functional Oversight of Site Contracting Representatives
- Conduct 1:1 training with ROW Site Contracting Representatives monthly
- Debrief with Management and escalate any resourcing concerns
- Point of Contact for all Budget Escalations for ROW budgets
- Participate in ROW study timelines discussions
- Advise management on ROW Site Contracting Timelines in study planning
- Liaise with legal counsel in resolving any legal issues/queries coming from sites
- Manage ROW GDPR Amendment Project through to completion
- Manage Site Contracting country knowledge database
- Escalation and Management of ROW CDAs
- Oversight and Management of CDAs and LOAs in assigned region
Contracts Associate III at PRA Health Sciences on assignment with Vertex
PRA Health Sciences
2017.12 - 2019.08
- Serve as primary point of contact with Investigative Sites for budget negotiations and manage site relationships to a high standard of excellence.
- Serve as primary point of contact between Legal and Investigative Site for project management of the contract.
- Reviews and evaluates Vertex requested contract changes based upon the guidelines provided and escalate budgets, as required, for fair market value assessments.
- Appraises contracts and budgets for completeness and accuracy and ensures adherence to department guidelines; corrects documents and files changes and ensure all budgets and contracts are tracked in their respective database.
- Liaise with Vertex legal and CRO to address and resolve any legal issues/queries coming from sites. Keep the team members abreast of urgent issues and status updates that may adversely impact study start up timelines.
- Attend and contribute to study-related meetings, as required.
- Demonstrates expertise and experience by providing mentoring and oversight to new Contract Associates.
- Works independently; analyzes and enhances strategies used for working with project teams and engaging sites.
- Exhibits leadership among peers and a willingness to take responsibility for follow up and on issues that arise in a timely manner.
Sponsor Contract Manager at Covance
Covance
2016.01 - 2017.10
- As a Sponsor Contracts Manager, level 1, my main role is to help support the team with the creation, maintenance and development of contracts, service agreements and other associated documentation. In addition, I am responsible for:
- Develop, review, and negotiate Confidentiality Agreements, Letters of Intent, Services/Consulting Agreements, Clinical Development Agreements, Master Services Agreements (including multi-unit MSAs) and Individual Project Agreements.
- Lead negotiations for all assigned Agreements with minimal management support
- Lead the identification, development and negotiation of Work Orders, Standalone Agreements, Change Orders for assigned projects
- Implement change management process for Agreements in accordance with Contract Management guidelines
- Perform cash flow analysis and generate payment schedules for Agreements in accordance with Contract Management guidelines
- Assist management with departmental initiatives, process improvements and strategic initiatives, as assigned
- Assist/mentor junior staff including providing pre-submission review and approval of junior staff’s signature documents in accordance with the Contract Management review guidelines, as assigned.
- Maintain accurate and timely reporting functions for all assigned projects
Global CTA Lead
PRA Health Sciences
2013.07 - 2015.12
- I worked at PRA Health Sciences as a Global CTA Lead and my main role was managing Clinical Trial Agreements and Negotiations on various studies across all phases of clinical trials in Europe and Asia Pacific.
- Tracking study progress and providing regular updates to Clinical Sponsors through scheduled weekly calls and reports.
- My other daily functions included: Acting as the main liaison between Clinical Sponsors and Sites & Contract Associates to maintain good stakeholder relationship and ensure we are working towards meeting study timelines.
- Provide training and support to other members of the team, acting as their mentor and ensure we meet Sponsor expectations in CTA delivery.
- Drafting, negotiating, and preparing Clinical Site Contracts (CTAs) and amendments for Sponsor studies with various sites across Europe.
- Drafting, negotiating, and preparing ancillary agreements including Pharmacy, Radiology, Investigator, CDA’s for sites (if applicable).
- Reviewing and implementing sponsor base budget to site budgets prior to negotiating with site and ensure it reflects FMV through comparison in Medidata.
- Negotiating budgets for clinical studies within Sponsor parameters and liaising with clinical sites to ensure accuracy and adaptation of sponsor budget.
- Managing and tracking the negotiation cycle to full execution of the CTA and ensuring CTMS and any additional document management platforms are up to date and accurate.
Executive Assistant to the Legal and Risk Directors
Barclays Direct
2008.12 - 2013.06
- I was responsible for providing general legal and administrative support to the Directors which included; Research into legal and regulatory matters, monthly reporting to HR and other areas of the business.
- Efficiently managing the communication exchange and relationship with other Executive Board of Directors and external partners of the business.
- Implementation of company policies and procedures.
- Managing the training budget.
- Drafting confidential internal/external documents and maintaining confidentiality as per NDA agreement.
- Supporting the wider risk and legal team in ad-hoc projects/tasks.
- Formerly ING Direct
RiO System Analyst/Administrator
NHS
2009.10 - 2010.08
- My main role was configuring and implementing RiO technical infrastructure to Health services across Berkshire.
Stockroom Management
NEXT Retail
2003.12 - 2008.08
- My main role was to monitor and reconcile the in-house replenishment systems.
- I managed six to ten employees in the stockroom at any one time.
- I was also responsible for training new employees and helping them integrate into the NEXT family.
Telemarketing Executive
Slipstream SDS Ltd
2006.12 - 2008.04
- My main role was primarily focused on uncovering and identifying tangible potential opportunities for our clients that ultimately lead to great ROI.
Volunteer Worker
2000.01 - 2002.01
- I volunteered as a support worker in various charitable organisations in Kenya.
- I worked in Christian sponsored homes for orphaned and abandoned HIV infants, home for the aged, cancer and orthopedic wards in public hospitals amongst other small charities.
- This experience has humbled me and taught me so much about humility and compassion for others.
Education
LLM, Masters - International Law and World Order
University of Reading
United Kingdom 2008.01 - 2009.01
LLB Law -
University of Reading
United Kingdom 2002.01 - 2006.01
International Baccalaureate - 5 subjects A- C grades
Saint Mary’s school
Nairobi, Kenya 2000.01 - 2001.01
O LEVELS - 8 subjects A- C grades
Mbooni Girls Secondary School
Kenya 1996.01 - 1999.01
Skills
- Microsoft Office
- ETMF
- CTMS
- Salesforce
- Icertis
Languages
Fluent in both written and spoken English
Fluent in Swahili
Others
- Student Rep for Postgraduates in the Faculty of Law; University of Reading 2008-2009.
- 2009 to 2013: I volunteered to work as an International Relations Officer for a London based NGO (Facilitate Global) where my main responsibility was to provide research into legal and regulatory matters and write articles in the realm of international law, international humanitarian law and global crisis on terrorism. Published articles available via my LinkedIn profile.
References
Available on request.
Interests
- Hiking
- Swimming
- Zumba
- Basketball
- Gym
- Outdoor recreational activities
Timeline
Regional Site Contracting Manager (International)
2020.06 - 2023.06
REGIONAL SITE CONTRACTING MANAGER, Clinical Budget Management on assignment with Vertex
Vertex
2019.09 - 2020.06
Contracts Associate III at PRA Health Sciences on assignment with Vertex
PRA Health Sciences
2017.12 - 2019.08
Sponsor Contract Manager at Covance
Covance
2016.01 - 2017.10
Global CTA Lead
PRA Health Sciences
2013.07 - 2015.12
RiO System Analyst/Administrator
NHS
2009.10 - 2010.08
Executive Assistant to the Legal and Risk Directors
Barclays Direct
2008.12 - 2013.06
LLM, Masters - International Law and World Order
University of Reading
2008.01 - 2009.01
Telemarketing Executive
Slipstream SDS Ltd
2006.12 - 2008.04
Stockroom Management
NEXT Retail
2003.12 - 2008.08
Associate Director, Clinical Site Contracts (International)
Vertex Pharmaceuticals
2003.07 - 2026.02
LLB Law -
University of Reading
2002.01 - 2006.01
Volunteer Worker
2000.01 - 2002.01
International Baccalaureate - 5 subjects A- C grades
Saint Mary’s school
2000.01 - 2001.01
O LEVELS - 8 subjects A- C grades
Mbooni Girls Secondary School
1996.01 - 1999.01