Molly Grosse
Holly Springs
Summary
Extremely motivated Director with proven history of leading high-performing teams and executing strategic initiatives that drive organizational growth. Successfully directed cross-functional projects that resulted in significant process improvements and operational efficiencies. Demonstrated leadership and communication skills in fostering collaborative environments and delivering impactful results. Specializing in study start-up and skilled at planning, implementing and overseeing key improvements to drive business growth and efficiency. History of cultivating an open culture with free exchange of information. Proven leadership and communication skills with project team members, line managers and directors within Clinical Operations, Global Study Start-up and Project Management. Provided operational leadership to effectively manage the activities of Clinical Operations and supervise people (multiple locations and or regions) in a manner that ensures all delivery targets are met with highest quality, whilst balancing productivity, resourcing, revenue and margins. Responsible for management of People Leaders as well as oversight of staff including performance feedback, training and mentoring, supporting growth and career development. Responsible for global departmental initiatives focused on process improvement resulting in more streamlined processes, greater efficiencies, quality improvements and decreased cycle times. Pursuing new professional challenges with a growth-oriented company.
Overview
21
21
years of professional experience
Work History
Director, Clinical Operations – Americas Regional Head, Study Start-up Management
ICON
04.2024 - Current
- Owns the overall direction, strategy and performance standards for the Americas Region, inclusive of Managers, and all levels of Site Activation Leads
- Responsible for oversight of ~80 employees across North and Latin America. Proven experience with restructuring and consolidation of teams
- Responsible for implementing an effective structure and processes to ensure accelerated site activation timelines in their countries or customer, and with highest quality
- Monitoring and improving key performance metrics around reduced cycle times, predictability of delivery, and enhanced productivity, and will comprise oversight over key customer, operational and financial activities
- In addition to providing operational leadership to the group, the Director, Study Start-Up is knowledge in local regulations, act as a senior counterpart to internal customers and ensure growth of their customer and/or countries
- Schedules and reviews project tasks to ensure high quality product is delivered on time and within the budget
- Ensures services provided to clients are compliant with ICON’s policies, procedures, SOPs, ICHGCPs, client contractual expectations and country specific regulatory requirements
- Manages operational budget for the unit(s)
- Mentors and develops employees to expand employee performance levels and assure retention of high performing ICON employees
- Ensures appropriate employee resources are available to meet corporate/ client/ project objectives while achieving optimal billability of clinical operations staff
- Accurately projects resource needs to ensure timely hiring of clinical operations staff. Adjust resource allocation for project work as appropriate to ensure corporate billability targets are maintained while assuring client/ project objectives are achieved
- Establishes processes and participates in ICON’s Quality Process Management continuous improvements by assuring that project quality metrics align with company, client and clinical operations objectives
- Provides input to central proposals for project bids to ensure all projects can and will be managed within contractually agreed upon schedules and budgets
- May function as legal representative for ICON in selected countries as appropriate
- Line management of assigned staff; including conduct and documentation of regular 1:1 discussions, ongoing communications, salary and performance reviews, as well as talent mapping and succession planning
- Developed high-performing teams by providing mentorship, guidance, and opportunities for professional growth.
- Enhanced team collaboration through regular communication, goal setting, and performance evaluations.
- Established a culture of continuous improvement by fostering open communication channels and empowering employees to voice their ideas.
- Cultivated a positive work environment that fostered employee engagement, increased retention rates, and boosted overall team morale.
- Implemented innovative solutions to solve complex problems, resulting in increased productivity and streamlined operations.
- Proactively identified potential risks and implemented mitigation strategies to minimize negative impacts on projects or business operations.
- Responsible for oversight of recruiting, hiring and training of team members.
Associate Director, Clinical Operations – Americas Regional Head, Study Start-up Delivery
ICON
12.2021 - 04.2024
- Owns the overall direction, strategy and performance standards for the Americas Region, inclusive of Managers, and all levels of Site Start up Associates
- Responsible for oversight of ~125 employees across North and Latin America. Proven experience with restructuring and consolidation of teams.
- Responsible for clinical operations activities and staff within the unit(s)
- Mentors and leads the clinical operations management team, maintains appropriate resources to achieve maximum staff billability and adheres to quality management practices
- Fostered a culture of continuous improvement by encouraging staff to share innovative ideas and providing resources for professional development.
- Provides leadership in the implementation of ICON's quality initiatives and business processes, achievement of management goals within the framework of the company mission, policy and philosophy
- Implements strategic direction to the Clinical Operations department
- Takes ownership for overall direction, strategy and performance standards across job disciplines to assure that profitability targets are achieved
- Drives strategic growth in line with emerging industry direction, client needs, and regulatory changes
- Ensures appropriate employee resources are available to meet corporate/ client/ project objectives while achieving optimal billability of clinical operations staff
- Regularly reviews resource needs to ensure timely hiring of clinical operations staff
- Reviews and approves hiring decisions as assigned by Vice President
- Takes action to adjust departmental resources at roll up level, as appropriate, to ensure corporate billability targets are maintained while assuring client/ project objectives are achieved
- Ensures services provided to clients are compliant with ICON’s policies, procedures, SOPs, ICHGCPs, client contractual expectations and country specific regulatory requirements
- Mentors and develops management team to expand performance levels and assure retention of high performing ICON Leaders
- Establishes processes and participates in ICON’s Quality Process Management continuous improvements by assuring that project quality metrics align with company, client and clinical operations objectives
- Identifies and leads initiatives to harmonize with global counterparts for consistency on project delivery
- Provides input to central proposals for project bids to ensure all projects can and will be managed within contractually agreed upon schedules and budgets
- Provides guidance/ insight on aspects of clinical operations, as well as contingency planning, to accommodate project or therapeutic-specific nuances while identifying potential impact to budget
- Solid understanding of ICON systems and able to relate that to process requirements
- Proven track record of personnel performance management
- Ability to manage and challenge management team in both career and personnel management
- Helps to review current processes as part of multi-functional teams in relation to process and systems
- Mentors and manages across management team
- Independently and proactively provides solutions to challenging issues
- Supervises functional managers
- Exerts influence in the development of overall objective and long-range goals of the organization
Senior Manager, Clinical Operations - Study Start-up Delivery
PRA Health Sciences
04.2018 - 12.2021
- Manage a high performing team of 15-20 Site Activation Specialists
- Responsible for oversight of study deliverables and Start-Up timelines; actively engage in risk mitigation strategies to successful achieve study milestones
- Mentors and trains other Clinical Operations management level employees:
- Designs and delivers relevant training to teams and/or management groups
- Mentor and go-to resource across all services within Clinical Operations group and as Subject Matter Expert by PRA staff outside of Clinical Operations
- Leading process development/improvement task force developing tool(s) to improve Clinical Operations processes acting as Subject Matter Expert (SME) for various initiatives
- Leadership on programs and/or initiatives that are increasingly complex in their scope of services, technology employed, volume, and/or revenue
- Assists more senior Clinical Operations staff in review, development and implementation of short term and long-term objectives, major plans and programs for each functional group within Clinical Operations
- Creates and maintains effective relationships between other PRA business units or functions
- Participates in internal/external audits and regulatory agency inspections, as required
Manager, Clinical Operations
PRA Health Sciences
01.2016 - 03.2018
- Manage and develop employees to ensure high quality work performance and retention of top employees
- Develops plans to support growth and career development of direct reports and manage delivery of quality performance in line with their job description
- Ensures staff development and performance feedback are provided through activities such as mentorship and career development
- Communicates team and individual goals and expectations to ensure direct reports understand their responsibilities
- Responsible for managing performance of staff, including providing input into salaries, bonuses and nominations for promotion
- Promotes positive and professional work environment that attracts and retains best talent and delivers services that exceed customer expectations
- Responsible for management of resources and resource projections; ensure project teams are consistent with client needs, expectations and contractual expectations
- Leading employees in delivery of services to clients; ensuring staff fulfill their responsibilities in accordance with company policies, procedures, SOPs, ICH GCP and other relevant regulatory requirements
- Provides leadership and implement services and productivity improvements to ensure optimal utilization of billable staff; perform metric collection and data analysis to support continuous improvement in policies, procedures, and business process
- Identifying and implementing process improvements through review of SOPs, processes; recommending improvement plans to senior management
- Leading task forces to implement process improvement initiatives
- Building teamwork and improving process and productivity by working within and across functional areas
- Act as point of escalation (internal) for resolution of issues and conflicts
- Evaluates compliance of assigned employees with PRA systems and processes
- Provides support with proposal development and participates in client presentations and/or bid defense meetings, as required
Resourcing Specialist III
PRA Health Sciences
04.2015 - 12.2015
- Assesses employee resources and resource projections to ensure that project teams meet client expectations and PRA contractual obligations
- Support Business Development through rapid RFP resource request fulfillment, including understanding sponsor requirements and expectations, building scenarios to match resource availability with future staffing needs and building dynamic cross-functional teams to enhance probability of project award
- Support Project Delivery in building and managing cross-functional teams across project lifecycle from initial award to final client deliverable
- Develop portfolio management strategies for key clients where multiple projects or development pipelines allow for migration and development of staff across programs
- Conduct continuous workforce / workload analyses to achieve appropriate balance (e.g
- Resource availability v
- Incoming work) and assess future staffing needs (e.g
- Workload ratio, recruiting needs, etc.)
- Collect, analyze & report employee skills data
- Assess resource needs and conduct risk assessments as related to achievement of project milestones (e.g
- IM, SIVs, CRF backlog, interim analyses, etc.)
- Interfaces with clinical staff across business units, providing input and feedback to promote quality deliverables
- Ongoing communication & consultation with internal customers
- Refine and enhance tools and processes to improve resourcing practice in response to changes in business need
- Responsible for strategic planning, assignment and tracking of Product Registration staff across proposed, new and existing projects
Sr. Country Start-up Specialist
PRA Health Sciences
11.2012 - 03.2013
- Resolves more complex informed consent and study documentation issues by exercising advanced judgment when interacting with study sites or assisting assigned team members
- May serve as primary CSS when multiple CSS's are assigned to large global studies or across programs with particular clients to ensure consistency across project(s)
- Mentors, coaches, and trains multiple IHCRAs, CSSs and other staff where applicable
- May participate in business development activities and answer strategic start up questions to other operational areas
- Recommends and implements enhancements to systems to improve project start up delivery
- Assists in writing and reviewing SOPs, work instructions or any other documentation to improve project start up delivery
Country Start-Up Specialist
PRA Health Sciences
11.2011 - 11.2012
- Oversees Local Ethics Committee (IEC) and other local authority submissions and approvals for their country/region or project as applicable
- Establish site activation forecasts and ensures critical path activities are on target
- Prepares and presents project-specific overview to Clinical Operations, Legal and Regulatory Affairs staff regarding start up deliverables, timelines and processes
- Assists CTM, GRAL and/or PM with forecast of units and hours and generic resourcing for IHCRA, LRAL and CA activities; determines worked units and hours and analyzes forecasted and worked activities to ensure adherence to contract and budget
- Creates, maintains and facilitates Sponsor Approval of project documents related to study start-up, including Informed Consent Checklist, Essential Document Review Requirements, Country and Site Standard Investigational Product Release forms
- Serves as primary liaison and primary point of escalation for project start-up issues for assigned countries
- Implements project start-up methodology, establishing baseline, target and current subject recruitment months and documenting information within Clinical Management Plan (CMP), CTMS and Project Start-up Summary
- Conducts meetings to ensure all relevant team members are kept current on timelines, clinical activities and contract and budget status
- Creates, maintains and facilitates Sponsor Approval of project status reports
- Oversees system compliance from IHCRAs and works with GRAL and/or Contracts Manager (CM) to address any system compliance issues from LRAL/Contract Associates (CA)
- Assesses and communicates impact of project scope on timeline changes and/or local resource requirements and escalates where necessary
- Collaborates with Global Regulatory Affairs Lead (GRAL) assigned to project to ensure Ministry of Health (MOH), Central Independent Ethics Committee (IEC) and other central submissions are performed in line with site activation timelines
- Escalates risks to project start-up timelines for assigned countries and works with Clinical Trial Manager (CTM) and/or Project Manager (PM) to mitigate those risks
- For assigned countries, provides timely status reports on project start-up activities for internal and client teleconferences
- Performs Independent QC of Investigational Product Release packages and other documentation (i.e
- Essential Documents and Informed Consent Forms) as determined by project specific process
- Oversees site identification and recruitment activities for allocated countries; including, liaises with other departments when additional sites are needed, and escalates delays, where applicable
- During Start-Up, assesses impact of study amendments on Informed Consent and other study documents and either updates documentation and/or works with GRAL/LRALs and/or IHCRA(s) to ensure quality amendments and submissions are made (where applicable)
- Ensures Time Entry Guidelines are adhered to, with support from CTM and GRAL, by IHCRA, CA and LRAL in line project scope and budget and escalating where necessary
- Oversees Local Regulatory Affairs Lead (LRAL) and In-House Clinical Research Associate (IHCRA) to ensure that essential documents for allocated regions, including Informed Consent Forms, are developed, collected, reviewed and tracked according to processes and timelines agreed upon on project
Sr. In-House CRA
PRA Health Sciences
03.2011 - 11.2011
- Reviews Essential Documents to ensure sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH guidelines
- Interacts with other project team members as required to facilitate study start up
- May oversee project Command Center staffing and maintenance as applicable
- Determines, tracks and reviews milestones, tasks, timelines, and projected hours for all clinical activities for assigned projects, ensuring adherence to contract and budget
- Recommends and implements enhancements to clinical systems to guarantee successful delivery
- Identifies out of scope tasks from non-monitoring clinical activities by clinical team and escalates to PM
- Serves as primary liaison for start-up and in-house site management issues, escalating to Project Manager or Global Clinical Project Manager as required
- Leads multiple In-House CRAs on project, providing training and mentoring as required
- Achieves successful delivery of start-up, in house site management and close out activities meeting internal and external client requirements
- Provides data as required for clinical operations performance metrics and project status metrics
- Ensures that clinical operations team is kept current on timelines, clinical activities, contract and budget status
- Arranges and manages routine review of essential documents within Trial Master File
- Ensures that all tasks meet client and PRA expectations, and are delivered in accordance with Contract, trial protocol, ICH-GCP and applicable Standard Operating Procedures (SOPs)
- Provides timely status reports for clinical activities on assigned projects
In-House CRA II
PRA Health Sciences
10.2009 - 02.2011
- Utilizes CTMS for accurate and efficient investigator recruitment
- Utilizes phone scripts, questionnaires, study site materials, and other assessment tools for use in evaluation of investigative sites
- Performs Investigator Evaluation and Recruitment
- Ensures sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH guidelines
- Performs Essential Document Collection and Review
- Provides quality review of informed consent template
- Liases with project team members regarding study sites issues
- Evaluates metric data to identify process improvements
- Documents site and client contact and study interactions in timely and professional manner
- Manages time and project requirements based on study contract, identifies and documents out of scope activities
- Performs Study Tracking to ensure that study files are current, accurate, and complete
- Acts as liaison with clinical supply/service vendors and other functional area team members to meet project team goals
- Supports Lead CRA/Clinical Team Lead/Sr
- In-House CRA/CRA in management of clinical budget and evaluation of study processes
- Tracks clinical trial management information in CTMS
- Participates in sponsor and project-related meetings and appropriately interacts with client and team
- Interacts with client(s), vendors and PRA functional areas as secondary project contact for clinical issues
- Assists with resolution of investigative site/data queries
- Provides clinical status information to team members and project management under guidance of Lead CRA/Clinical Team Lead/Sr
- In-House CRA
- Supports investigators in fulfilling their obligations with regards to submission according to local regulatory and IRB/IEC requirements
- Liaises with Internal and External customers to meet project specific goals
- Supports Lead CRA/Clinical Team Lead/Sr
- In-House CRA/CRA in management of investigational sites to ensure compliance with trial protocol, ICH-GCP and applicable regulations
- Assists with managing and training staff
Sr. Research Coordination Specialist
PPD
10.2008 - 10.2009
- Lead and mentor study activities associated with clinical trials to ensure applicable timelines and metrics are met, including all regulatory, legal and financial aspects in accordance with FDA GCPs, ICH Guidelines and Global SOPs
- Develop collaborative relationships with CRAs, investigative sites and client company personnel
- Accountable for review and transmission of regulatory documents and negotiation of clinical Study agreements, budgets and investigator grants
- Provide oversight of non-clinical aspects of complex, multifaceted programs for division or multiple divisions
- Possess ability to conduct investigator file reviews
- Immediate supervision of small group of employees where majority of time is spent performing same or directly related work of type supervised
- Responsible for assigning, reviewing or checking work
- May provide input and/or prepare performance evaluations
- Ability to review and retain knowledge of protocol
- Accountable for generating, resolving and clarifying queries and regulatory documents
Clinical Research Specialist
PPD
10.2007 - 10.2008
- Perform and coordinate study activities associated with clinical trials to ensure applicable timelines and metrics are met, including all regulatory, legal and financial aspects in accordance with FDA GCPs, ICH Guidelines and Global SOPs
- Develop collaborative relationships with CRAs, investigative sites and client company personnel
- Accountable for review and transmission of regulatory documents and negotiation of budgets and investigator grants
- Responsible for all study start up tasks
- Conduct quarterly investigator file reviews
- Ability to review and retain knowledge of protocol
- Accountable for generating, resolving and clarifying queries and regulatory documents
- Accountable for meeting applicable project timelines in accordance with Master Contract
- Facilitate effective communication between client company, vendors and project team in order to anticipate, identify and resolve issues for non-clinical/clinical aspects of assigned studies
- Contribute to research and project team by mentoring new members, assisting in preparation of projects tools, and sharing ideas/suggestions with team members
Project Assistant
PPD
06.2004 - 08.2005
- Assisted with site management of INSPRA study on heart failure
- Communicated with personnel at research sites and at Sponsor regarding various requests
- Performed regulatory document review, budget and contract revisions and negotiations, administrative duties, made payments to sites, study start up as well as maintenance processes and procedures
Education
Bachelor of Arts - Psychology
Meredith College
Raleigh, NC05-2004
Skills
- Visionary Leadership
- Strategic planning
- Problem Solving
- Customer Relationships
- Verbal and written communication
- Decision-making
- Operations management
- Project management
- People and Team management
- Creativity and innovation
- Employee development
- Change management
- Hiring and retention
- SOP Review and Harmonization
- Collaboration
- Efficiency and Time Management
Languages
English
Timeline
Director, Clinical Operations – Americas Regional Head, Study Start-up Management
ICON
04.2024 - Current
Associate Director, Clinical Operations – Americas Regional Head, Study Start-up Delivery
ICON
12.2021 - 04.2024
Senior Manager, Clinical Operations - Study Start-up Delivery
PRA Health Sciences
04.2018 - 12.2021
Manager, Clinical Operations
PRA Health Sciences
01.2016 - 03.2018
Resourcing Specialist III
PRA Health Sciences
04.2015 - 12.2015
Sr. Country Start-up Specialist
PRA Health Sciences
11.2012 - 03.2013
Country Start-Up Specialist
PRA Health Sciences
11.2011 - 11.2012
Sr. In-House CRA
PRA Health Sciences
03.2011 - 11.2011
In-House CRA II
PRA Health Sciences
10.2009 - 02.2011
Sr. Research Coordination Specialist
PPD
10.2008 - 10.2009
Clinical Research Specialist
PPD
10.2007 - 10.2008
Project Assistant
PPD
06.2004 - 08.2005
Bachelor of Arts - Psychology
Meredith College
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