Helen Greta Antony Raj

Director, Project Management

North America Project Management team Oversight at Cenduit. Support Digital Patient Organization leadership, Chief of staff to BU Head ,

Achievements:
Instrumental in the operationalization efforts for product launches and study delivery in 2023, this continues for newer products in 2024.
Oversight and support with the operationalization of the product (Interactive Response Technology (IRT), Electronic Clinical Outcome Assessments (eCOA), and Electronic Consent (eConsent)) have been commendable.
Oversight and influence on NNB and Revenue for the entire business unit, possessing strong knowledge in project finance, supporting the project management team.
Led and supported the switch to Cenduit's revenue recognition model, Estimate at Completion (EAC), streamlined the entire process, and facilitated Project Management adoption. Streamlining change order revenue and monitoring study profitability are some of the recent initiatives that will significantly help growth in 2024.
Supports Sales teams with training, bid defense meetings, and proposal requests. Additionally, in the capacity of Chief of Staff for the BU head, spearheads a number of internal initiatives (running leadership meetings, preparing monthly data metrics, and strategy meetings).
Takes ownership of her work, applies constant client focus, and is a strong critical thinker and team player.
Played a significant role in achieving Cenduit's 2023 Revenue and NNB numbers due to her contributions to both EAC and Sales operations support.
In 2023, Helen supported many functions including Sales, Finance, Marketing, Contracts, Pricing, Legal, Project Management, Orchestrated Solutions, and served as Cenduit's point of contact for Clinical Tech and RDS.

Key Responsibilities

Document, analyze, improve, and communicate PMG's internal processes to increase efficiency and scalability.

Manage resources and staff, including recruiting, performance management, rewards & recognition, employee relations, and problem resolution. Participate in proposal development and attend sales/proposal presentations.

Support more senior department management in developing the department's goals, managing control spend, and maximizing revenue. Participate in the regular review and updating of department SOPs, ensuring direct reports are trained. Lead department meetings and provide relevant information, including project and process updates and key performance indicators. Work with the Technical Operations Group to ensure information flows between the two departments. Identify and execute process improvement initiatives by applying project management methodology to increase efficiencies and effectiveness within the Project Management Group (PMG).

Associate Director, Project Management

APAC Project Management team Oversight at Cenduit

Achievements
Under my leadership, Cenduit experienced significant growth in the APAC team throughout 2020 and 2021. I streamlined the project management team by establishing support functions in India.
I was instrumental in forming the PMA team before transitioning to other LMs.
I restructured the team and managers based on employee feedback and organizational focus.
I provided APAC sales enablement support, assisting customer meetings in China, Japan, and India.
I instituted CSAT and RAG status for all live projects and managed them on a monthly basis.
I played a key role in running organization-level WIGs (Wildly Important Goals).
I led the EAC rollout post-acquisitions and harmonized the contracting process for both Direct and CROPT customers.
As part of the M&A team, I supported the full transition from Cenduit legal entity to IQVIA.
Key Responsibilities:
Recruit, train, and develop staff in accordance with company procedures, ensuring that resource levels meet project requirements and milestone targets.
Directly manage and mentor assigned staff, including assigning work, conducting performance reviews, and setting career objectives in a manner that promotes employee development, purpose, direction, and motivation.
Oversee the project team to finalize required documents and study processes.
Meet with team members regularly regarding project tasks to monitor project milestones and communications with sponsors.
Ensure team members assess the clinical protocol and other supplied study specifications, working with cross-functional contacts to design supply chain solutions that meet the needs of the trial.
Resolve or advise on issue identification and escalation.
Work with direct reports to ensure all activities come together in a timely manner – this includes supporting direct reports in overcoming barriers to service delivery.
Participate in proposal development and sales/proposal presentations, ensuring that defense bids, customer visits, and teleconferences are fully resourced. work with business development to develop business leads and market intelligence.
Assist in identifying, developing, and implementing business process improvements on a global basis.
Participate in the regular review and updating of SOPs, ensuring direct reports are trained or made aware of any changes and communicating with others who may be impacted by the change.
Take part in management meetings to provide relevant information, including project updates, metrics, and key performance indicators. I work with Technical Operations managers to address issues and ensure smooth information flows between the two departments.
Evaluate the probability and impact of risks; I develop and implement quality and risk management plans for minimizing the impact on project objectives and deliverables.
Provide technical expertise and project management experience and guidance to staff cross-functionally.
Accountable for team performance and deliverables.
Undertake ad hoc duties as directed and agreed upon with senior management.

Sr. Manager, Project Management

APAC Project Management team Oversight at Cenduit

Key Responsibilities

Train and develop staff, in accordance with company procedures.

Direct management and mentoring of assigned staff, including the assignment of work, performance reviews, and career objectives.

Oversee project team to finalise required documents and study processes.

Meet with team members on a regular basis regarding project tasks to monitor project milestones and communications with sponsors.

Ensure team members assess the clinical protocol and other supplied study specifications, working with cross-functional contacts to help design supply chain solutions to meet the needs of the trial.

Resolve/advise on issue identification and escalation of issues.

Work with direct reports to ensure all activities come together in a timely manner – this could include supporting direct reports to overcome barriers to service delivery.

As appropriate, may manage individual studies and tasks.

Participate in sales/proposal presentations.

Assist in identifying, developing and implementing business process improvements.

Participate in the regular review and updating of SOP’s ensuring direct reports are trained or made aware of any changes and communicating with others who may be impacted by the change.

Take part in management meetings to provide relevant information including project updates, metrics and key performance indicators

Work with Technical Operations managers to address issues and ensure smooth information flows between the two departments.

Provide technical expertise and project management experience and guidance to staff cross-functionally.

Accountable for team performance and deliverables.

Undertake ad hoc duties as directed and agreed with senior management.

Manager , Project Leadership

PMA Line Manager

Key Responsibilities

Manage staff in accordance with the organization's policies and applicable regulations.
Responsibilities include planning,
assigning, and directing work; appraising performance and guiding professional development;
rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.
Participate in the selection and onboarding process for new staff by conducting candidate reviews and participating in the interviewing process. Conduct onboarding training for new staff in conjunction with Human Resources and Global Talent training programs.
Ensure that staff have the proper materials, systems access, and training to complete job responsibilities. Provide oversight for the execution of the training plan, Standard Operating Procedures (SOP) review, and mentored training experiences, as applicable.
Participate in the allocation of resources to projects by assigning staff to studies that are appropriate to their experience and training.
Manage the quality of assigned staff's work through regular review and evaluation of work products.
Identify quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in the performance of staff.
Ensure that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by management.
Assist in ensuring consistent standardized processes are implemented and department deliverables meet expected quality, financial, and productivity targets.
Ensure timely movement of project work through the process steps, in accordance with governing documents.
Develop specialist expertise in aligned specialist areas, as well as applying them across various functions.
Prepare presentation materials for department meetings.
Work constructively in a matrix framework to achieve project and internal stakeholder deliverables. Actively contribute to initiatives and work in close collaboration with the Operations team.
Participate in Department quality and/or process initiatives.
Mentor Leads/Associate Managers as assigned.
Assist in meeting department financial objectives by estimating requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions.
Standard Operating Procedures (SOP) and working instructions.

Clinical Project Manager
Project Manage studies across India, the Middle East, Northern Africa, and Eastern Europe, Line Management, Regulatory Contact

Key Responsibilities:
Responsible for the successful completion of projects and ensuring project team members take necessary actions to this effect
Responsible for ensuring that all the projects under management are on or below budget specifically
Routinely track and manage the Direct and indirect costs
Ensured all projects under management are on or ahead of schedule within client expectations
Ensured that all projects stay on target with regards to client expectations and deliverables
Prepared and presented material at scheduled study team meetings and sponsor meetings
Involved in study proposals to the clients, contract negotiation, preparing and coordinating for the change orders.
• Received several appreciations from the clients and Senior Management for efficiently managing the projects within stringent timelines and budgets
• Have been assigned as project oversight for other PMs when managing challenging studies and clients.
• Have received appreciations for making a difference.
• Traveled periodically to sponsor and sites as needed.
• Manage and Mentor teams on an ongoing basis, manage escalations.
• Work on all study-related contracts including sites, vendors, and contractors.
• Involved with preparing project plans, monitoring plans, site manuals, etc.

Additional Responsibility
Line Management - since 2009
• Managed several resources over a span of 5 years
• Managed overall activities for the reporters
• Periodic review and annual appraisals,
• Ensuring employee training needs
• Coordinated with senior management for the employees' FTE and
• assignment of studies based on the FTE.
• Ensure overall growth and satisfaction for the employees
• Excellent people management skills.
Regulatory Affairs - Regulatory Manager
• Main point of contact for the Indian regulatory.
• Responsible for Clinical trial submissions,
• Coordination and preparing for face-to-face meetings with regulators
• Providing necessary clarification to the regulatory within the required timeline for all studies managed.
• Managed all notifications from the start till the end of the study including (SAE, annual reports, site-specific changes, end of study reports, etc.)
Trainings:
• Attended and hosted several workshops for monitors on all topics of Clinical Research.
• Attended several Project Management trainings.
• Trainings attended on all essential topics in clinical trials.

Clinical Team Lead
Manage projects in India, including Line Management
Key Responsibilities:
Implement tools and procedures within the team to ensure process uniformity
Ensure coordination of activities across project sites
Ensure progress updates are received from all study participants and keep everyone informed of project issues
Communicate updates regularly with the sponsor in the specified frequency and format
Effectively communicate project developments and issues to the in-house team
Identify quality issues within the study through regular review of team communications; implement appropriate corrective action plans as needed
Identify and shortlist suitable vendors to be proposed to the sponsor
Responsible for effective management of selected vendors
Responsible for site budget negotiations and supporting the monitors in site budget negotiations
Help prepare the investigator contract for the study and review the contract
Ensure execution of investigator contracts before study startup activities are initiated
Track and verify invoices from the site to ensure correct, on-time payments are made
Train and guide the team to ensure that the team has clarity on all project responsibilities and applicable regulations regarding study procedures
Support the project team in their activities, identification, and provide resolutions
Co-mentor to assess the monitoring efficacy and site issues

Sr. CRA

Clinical Monitoring

Key Responsibilities:
Identified potential research investigators for phase III and therapeutic equivalence trials (Cardiology, Diabetes, Nephrology, Psychiatry, Dermatology, Oncology, Gynecology, Neurology, etc.). Monitored onsite clinical trials for Phase III trials. Possess deep knowledge in monitoring procedures, including site selection, initiation, interim monitoring, and close-out.
Experienced in ECRF monitoring and data query resolution.
Resolved data discrepancies and ensured complete and accurate data by reviewing source documents.
Reviewed protocols, CRFs, Investigator's Brochure, and informed consents.
Reviewed and approved site visit reports.
Created and updated SOPs, including general and study-specific ones.
Designed informed consent forms, diary cards, CRFs, site manuals, and templates.
Led overall activities and optimized the performance of the study team.
Monitored and tracked study progress, such as patient recruitment and protocol compliance.
Managed studies to agreed timelines.
Handled sponsor communications, including presentations, regular telecoms, and study progress updates.
Coordinated with outsourced CROs and other vendors.
Interacted with Data Management, experienced in the review of Data Management Plan, Statistical Analysis Plan, Data Validation Plan, Safety Management Plan, and Data Evaluation Plan.
Trained several CRA/CRC batch students at Lotus Clinical Research Academy on various topics of clinical research. Also trained internal and external study staff in study-specific procedures, general SOPs, and study-specific SOPs.
Provided on-site training to CRAs by accompanying them for site visits.

Tutor in Biology, mentoring the 10th grade students.

Clinical Research Associate - Clinical Monitoring

Key Responsibilities:

Collecting Trial feasibility Data with several Investigators across therapeutic areas (10 Trials).

Collecting Site feasibility data from a number of Hospitals (potential sites).

Site Co-ordination.

SOPs Creation.

Provided ICH-GCP training to the new hires.

Clinical trial related web based research.

Creation of Investigator Data base across therapeutic areas.

Trained the staff on Open Clinical (Clinical Data management software).