AbbVie

Associate Director, Study Feasibility

Musician

I frequently collaborate with other musicians to create original music. I dream to connect with others through songs.  

Musician for hire 
*Events (Weddings, funerals, parties, etc);
*Studio Musician/Back-up Vocalist in various bands of various genres; 
*Songwriting and arranging; 
*Live performances; and 
*Voice lessons

Vanessa Lynch

Clinipace

Senior Manager, Feasibility & Clinical Development

DOCS

Sr Feasibility Manager, performing Services for Clinical Insights and Experience at Janssen R&D

Accelerated Enrollment Solutions

Global Site Activation Manager/Study Start-Up

Manager, Strategic Feasibility 

Captain: Acts as primary point of contact for the SIA Country Project Team in USA/Canada and 
coordinates SIA Country Team activities and updates to the team. Provides project specific local
submission strategy and maintains a clear understanding of the country status details. Responsible for
identifying, escalating & mitigating risks, driving efficiencies and improving team ability to hit site
activation projections. Works with the STM and the other project stakeholders, streamlines
communication in and out of the SIA Country Team. Drives the complete country critical path to site
activation and facilitates handover to Clinical Management Team. 
 Occasionally, when needed, liaise with the Sponsor to discuss and implement North America Start-Up activities. 
 Prepare, review and coordinate local regulatory submissions (MoH, EC, additional special national local applications if applicable), in alignment with global submission strategy. 
 Develops and implements local submission strategy and provides technical expertise and coordination oversight for projects in collaboration with relevant internal departments. 
 Primary contacts for investigators and for local regulatory departments to ensure submissions are
managed in a timely manner. 
 Key-contact at country level for all submission-related activities and participate as required in Submission Team Meetings, Review Meetings and Project Team meetings 
 Ensures alignment of submission process for sites and study are aligned to the critical path for site
activation. 
 Prepare the regulatory compliance review packages, as applicable, as well as liaise within SIA locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy. 
 Develop the country and sites specific ICF
 Mentor several employees on a daily basis; Conduct 1-1 and group trainings to staff from various departments; Develop training material and resources for  team

Sr. Country Approval Specialist

Senior Feasibility Site Liaison Specialist

•	Develops site lists, including research from internal and external sources to ensure the site list is reflective of the defined site profile. Ensures current investigator and site staff contact details are appropriately maintained in PPD systems. 
•	Accountable for completion of the ‘Site Interest Plan’ in CTMS and collection and delivery of associated documents from investigators and site personnel. Document in real time all communication, attempts and follow up associated with site contact and survey responses.  
•	Reviews survey data to ensure responses are logical, complete and reflective of the question asked. 
•	Works in collaboration with SF Specialist to achieve targeted response goals for assigned projects. Communicates with the Strategic Feasibility team, appropriate SI&A and clinical personnel regarding site issues and feasibility risks.  
•	Ensures an efficient, effective plan is in place for site contact and follow up.  Ensures compliance with the plan and escalate concerns/non-compliance to SF Specialist and SF Manager.
•	Serves as the local expert regarding site capacity and expertise. Works with key local personnel to gather knowledge base and recommend additional sites. Harnesses this knowledge base when performing local tiering of sites. 
•	Where applicable, develops and maintains relationship with client local affiliates
•	Champions the inclusion of Strategic Collaboration sites into the feasibility process
•	Conducts phone interviews, scripted or non-scripted, with physicians and other site personnel to discuss standard of care and obtain protocol-level input to support trial optimization projects  
and more!

Feasibility & Site Liaison Specialist

*Ensures current investigator and site staff contact details are appropriately maintained in PPD systems. 
*Completes the ‘Site Interest Plan’ in CTMS and collection and delivery of associated documents from investigators and site personnel. 
*Supports the review of survey data to ensure responses are logical, complete and reflective of the question asked. 
*Works in collaboration with SF Specialist to achieve targeted response goals for assigned projects. Communicates with the Strategic Feasibility team, appropriate SI&A and clinical personnel regarding site issues and feasibility risks. 
*Ensures an efficient, effective plan is in place for site contact and follow up. Ensures compliance with the plan and proper escalations.
*May act as the local expert regarding site capacity and expertise. Work with key local personnel to gather knowledge base and recommend additional sites. 
*Where applicable, develops and maintains relationship with client local affiliates
*Champions the inclusion of Strategic Collaboration sites into the feasibility process
*Conducts phone interviews with physicians and other site personnel to discuss standard of care and obtain protocol-level input to support trial optimization projects 
*Liaises with Global Investigator Services to resolve investigator queries in real time and maintain ‘accounts and contact’ information
*Trains new FSLA’s on strategic feasibility processes and systems.
*Utilizes local knowledge to input into the identification and development of new Strategic Collaboration sites within local market
*Contributes to discussions with FSLA’s in other regions to support a collaborative network with consistent processes and sharing of best practices.
*Serves as a subject matter expert on feasibility survey tools and provides input on the development of future systems/releases. 
•Expands therapeutic knowledge and expertise (where country structure permits TA alignment of role)

Feasibility & Site Liaison Associate

Responsible for providing project administrative support to Clinical Team Managers, Project Managers and/or CRAs in Site Intelligence Activation.

•	Responsible for communicating with sites for scheduling pre-study visits, discussing feasibility concerns and/or questions, and setting a remarkable first-impression of PPD.
•	Responsible for scheduling on-site and remote pre-study visits for approximately fifteen (15) SIA CRAs in addition to multiple clinical CRAs across North America.
•	Responsible for achieving monthly SIA PSV targets 
•	Coordinate accompanied field visits.
•	Assisting other PAs, CTMs, PRCS’, and PMs when necessary.
•	Responsible for the background administration and preparation for trial set up, monitoring, and tracking 
•	Maintaining project files and documentation according to relevant PPD SOPs and WPDs
•	Assisting in the organization of investigator, CRA, project team, and client meetings
•	Maintaining tracking databases eg. PPD CTMS, Excel

Project Assistant - SIA

Steele Music Studios

Voice Teacher

Brax Spiritcups Fundraising

Founded in 2005, BRAX Fundraising is a Wilmington, NC based organization whose mission is to help schools and youth sports teams exceed their fundraising goals by offering products officially licensed by the National Football League (NFL), Major League Baseball (MLB), over 90 top colleges and five branches of the US Military. BRAX operates independently and in partnership with the NFL, National Dairy Council, USA Football, Pop Warner, The Miracle League and other leaders in youth health, fitness and academics

I generated new business leads, reached out to them, and helped them run successful fundraisers and meet and exceed their fundraising goals! :)

New Business Development

Coble Law Firm, PC

Pleasantly answer phones and assist clients; take detailed messages for the attorneys; accurately 
bill clients for attorney time spent on files via telephone, meetings, and correspondence;  draft 
correspondence; draft Small Claims, District and Superior Court pleadings; draft discovery 
documents; make phone calls on behalf of attorneys to firm clients, opposing attorneys and 
county courthouses; file pleadings and other court documents with the county courthouses and 
Sherriff’s department; conduct research regarding NC statutes and case-law; pleasantly greet and 
assist all clients that visit the office; administer accounts payable and receivable; in-house filing; 
cloud filing; thank-you and holiday cards; marketing; and training of new hires;

Office Manager/Legal Assistant

Music and Clinical Research...the wonderful yin and yang of my life. I’m a unique clinical research professional with specialities in new role development, training and mentoring, process improvement, study start up management, and feasibility analysis, strategy, and management. No challenge is too hard to conquer as I always bring my creative side and outside-of-the-box thinking into whatever I do! I look forward to our connection!
Vanessa

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