Michele Calhoun Email & Phone Number

Morrisville, Nc, Us

• Responsible for the recruitment and line management of clinical operations staff including staff resourcing; communicating job expectations; planning, monitoring, and appraising job results; coaching, counselling, and disciplining employees; and developing, coordinating, and enforcing policies, procedures, and productivity standards.• Responsibilities include mentoring and directly supervising all direct reports, ensuring client satisfaction, and participating in initiatives for improving quality, utilization, efficiency, and resourcing.• Manages clinical projects by ensuring quality and customer service; analyzing and resolving quality and customer service problems; identifying trends; recommending system improvements.• Builds and maintains long-term rapport and relationships with customers to ensure their expectations are continuously exceeded.• Takes the initiative to understand customers’ technical and business challenges and identifies ways to improve upon and expand the scope of existing relationships.• Supports business development activities by participating in project costing estimates, proposal reviews/change order management and proposal defenses as needed.• Manages the resource allocation and utilization for his or her team in conjunction with the project goals for the department.• Administers financial compensation for direct reports and proposes adjustments (e.g., promotions, market adjustments, etc.) to management.• Represents the clinical team in audits and in corporate initiatives, as appropriate.• Provides support, mentoring, and training to staff as needed.• Completes assigned project work and study-related activities such as monitoring, report writing, or other related tasks as a working manager.• Performs additional duties as assigned.

Dublin , Gb

Manage and develop PRA employees to ensure high quality work performance and retention of high quality employees." Develops plans to support growth and career development of assigned Clinical Operations employees as well as manage the 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 theirResponsibilities. " Responsible for managing the performance of staff of 41 members, including providing input into salaries, bonuses as well as nominations for promotion." Promotes a positive and professional work environment that attracts and retains the best talent and delivers services that exceed customer expectations." May conduct assessment visits with staff as required by SOPs" Responsible for the management of resources and resource projections to ensure project teams are consistent with client needs, expectations and contractual expectations by reviewing project tasks and timelines and assigning team members.

Dublin , Gb

• Ensured the successful negotiation and on-going management of clinical trial agreements with investigative sites.• Identified and proactively raised issues to the CTA Lead or CM, as appropriate, prior to their becoming critical or creates risk.• Communicated and explained legal/ budgetary issues to internal and external parties per department guidelines.• Advanced consistency, timeliness and completeness of all interactions with site in database. • Participated in client meetings for the purpose of expediting the contract signing process as directed. • In partnership with CTA Lead and others as necessary, evaluated priorities and quickly readjusts priorities with the changing needs of business and the client.• Worked independently; analyzed and enhanced strategies used for working with project teams and engaging with client sites.• Created and maintained files for each contract.• Tracked all site interaction in database in a timely and accurate manner and ensured that status updates were fully descriptive.• Worked cross functionally with Clinical Operations and Project Management in support of timely site start up for the conduct of clinical trials including accurate forecast of contract execution timelines. • Reviewed and evaluated client requested contract changes and based upon department guidelines escalated deviations as appropriate.• Appraised contracts for completeness and accuracy and ensures adherence to department guidelines; corrected documents and files changes to contracts.• Generated ideas and solutions to improve requested contract/budget changes while appropriately partnering with Functional Manager and/or CTA Lead for feedback and execution.• Worked with Department in the training of new database system and updated all training materials as needed.• Worked as Study Lead on studies by managing other site contracting associates to troubleshoot issues.

Dublin , Gb

• Ensured the successful negotiation and on-going management of clinical trial agreements with investigative sites.• Worked cross functionally with Clinical Operations and Project Management in support of timely site start up for the conduct of clinical trials including accurate forecast of contract execution timelines. Created and maintained files for each contract.• Participated in client meetings for the purpose of expediting the contract signing process as directed. • Exhibited proficiency in managing multiple projects and clients with competing priorities • Escalated to CTA Lead role on studies for which they provide support to CA’s and PA’s assigned to study, including mentoring and ensuring that all sites are handled in accordance with department guidelines. Appraised contracts for completeness and accuracy and ensured adherence to department guidelines; corrected documents and filed changes to contracts.• Advanced consistency, timeliness and completeness of all interactions with site in database. • Exhibited increasing proficiency in executing documents that were complete and accurate delivered within shorter timeframes.• In partnership with CTA Lead and others as necessary, evaluated priorities and quickly readjusted priorities with the changing needs of business and the client.• Enhanced skill at discerning and responded to issues at sites that pose risk and escalating accordingly. • Identified and proactively raised issues to the CTA Lead or CM, as appropriate, prior to their becoming critical or creates risk.• Tracked all site interaction in data base in a timely and accurate manner and ensured that status updates were fully descriptive.• Collaborated with the Functional Manager who will partner with other compliance departments to ensure country specific laws and regulations are followed to minimize risk in clinical trials. • Communicated and explained legal/ budgetary issues to internal and external parties per department guidelines.

Wilmington, Nc, Us

•• Performed and coordinated all activities required to finalize site contracts (including, contractual terms and conditions, associated investigator grant budget(s) payment schedule terms and conditions and ancillary documents), with investigator sites, pharmacies, laboratories or other relevant contractual parties during the lifecycle of the study.• Reviewed PPD and/or client site contract templates for compliance with local legislation and practices. • Acted as team lead/point of contact to provide information and guidance with study teams.• Served as contact with investigative sites for contractual issues and negotiations throughout the lifecycle of a study.• Performed and coordinated all amendments to site contracts and financial agreements with investigator sites, pharmacies, laboratories or other relevant contractual parties during the lifecycle of the study. Assumed responsibility for any ongoing contract or budget amendments.• Adapted site contract template to client and investigational site requirements in collaboration with key stakeholders to include the project team and the PPD legal team.• Facilitated effective budget negotiation with site personnel in collaboration with key stakeholders.

Wilmington, Nc, Us

• Performed and coordinated all activities required to finalize site contracts (including, contractual terms and conditions, associated investigator grant budget(s) payment schedule terms and conditions and ancillary documents), with investigator sites, pharmacies, laboratories or other relevant contractual parties during the lifecycle of the study.• Served as contact with investigative sites for contractual issues and negotiations throughout the lifecycle of a study.• Facilitated effective budget negotiation with site personnel in collaboration with key stakeholders. • Performed and coordinated all amendments to site contracts and financial agreements with investigator sites, pharmacies, laboratories or other relevant contractual parties during the lifecycle of the study. Reviewed PPD and/or client site contract templates for compliance with local legislation and practices. • Adapted the site contract template to client and investigational site requirements in collaboration with key stakeholders to include the project team and the PPD legal team.• Assumed responsibility for any ongoing contract or budget amendments.

Wilmington, Nc, Us

• Prepared Request for Proposals (RFPs) for sponsors and negotiated budgets for to secure new business.• Selected, trained, motivated, managed and evaluated analysts to prepare revise and evaluate all aspects• of proposal development for selected clients.• Processed and prepared contracts, Contract Modifications and CNFs for awarded opportunities. Drafted, coordinated and finalized RFPs, revisions of proposals, and contract modifications for clients. Processed signatures of Contract Modifications, CNFs etc. and routing to client.• Managed and assisted up to five (5) business development salespersons with key accounts in their daily activity with clients.• Managed shared mailbox for new RFPs and revisions to ensure proper bidding team is allocated. Processed and distributed weekly reports summarizing new business actively processing to department and coordinating departments responsible for assembling proposals. • Served as Team Leader for all temporary and intern positions within Commercial Coordinator team.• Served as liaison between salesperson, client and company to resolve conflicts, ensure questions are answered for proposals and revisions of proposals, and pursue contracts until final signature is obtained.• Assisted in preparing preferred provider rates and language for key accounts.• Coordinated information between CP&D department and entire company to ensure all new RFPs and revisions to RFPs are communicated to bidding team.• Processed Contract Modification shared mailbox to ensure all new modification requests and Change Notification Forms (CNFs) are routed to team for processing and/or signature.

Wilmington, Nc, Us

• Prepared written bids, proposals and budget estimates in response to RFPs, for submission to sponsors.• Provided line supervision and managed colleagues within team and department.• Served as Account Lead on strategic account and managed team to ensure deadlines were met. Participated in client meetings (face-to-face and via teleconference) with sponsors to win business for PPD.• Assisted in the training and mentoring of colleagues.• Resolved diverse problems with sponsors and PPD personnel to overcome obstacles through in-depth evaluation and financial analysis of various factors including identifying, assessing and mitigating potential risk. • Made modifications to existing proposals and contracts while tracking revisions from start to completion.

Wilmington, Nc, Us

• Prepared Request for Proposals (RFPs) for sponsors and negotiated budgets to secure new business.• Managed and assisted up to five (5) business development salespersons with key accounts in their• daily activity with clients.• Served as liaison between salesperson, client and company to resolve conflicts, ensure questions are answered for proposals and revisions of proposals, and pursue contracts until final signature is obtained.• Processed and prepared contracts, Contract Modifications and CNFs for awarded opportunities. Drafted, coordinated and finalized RFPs, revisions of proposals, and contract modifications for clients. Processed signatures of Contract Modifications, CNFs etc. and routing to client.• Selected, trained, motivated, managed and evaluated analysts to prepare revise and evaluate all aspects of proposal development for selected clients.• Processed Contract Modification shared mailbox to ensure all new modification requests and Change• Notification Forms (CNFs) are routed to team for processing and/or signature. Assisted in preparing preferred provider rates and language for key accounts.• Coordinated information between CP&D department and entire company to ensure all new RFPs and revisions to RFPs are communicated to bidding team.• Managed shared mailbox for new RFPs and revisions to ensure proper bidding team is allocated. Processed and distributed weekly reports summarizing new business actively processing to department and coordinating departments responsible for assembling proposals. Served as Team Leader for all temporary and intern positions within Commercial Coordinator team

Wilmington, Nc, Us

• Drafted, coordinated and finalized Request for Proposals, revisions of proposals, contracts and contract modifications for clients.• Reviewed all incoming and outgoing contracts from beginning stages through final contract for improper or unacceptable legal language.

Wilmington, Nc, Us

• Assisted Director of department in all secretarial responsibilities.• Reviewed and allocated personnel to prepare Request for Proposals for clients.• Directed daily Bid Review call for department which reviews outgoing proposals for financial scrutiny. Scanned, filed and coordinated all aspects of department file room.

Lead Weight Watcher meetings to existing and new members to educate, motivate and assist in their weight loss journey.

• Advised attorneys of all appointments, filing dates and deadlines.• Assisted in the preparation of voluntary bankruptcy petitions.• Monitored and directly responsible for the office bank account and trust account. Paid and monitored all bills of the office, including personal affairs for the owner

Raleigh, Nc, Us

• Assisted clients with estate administration from inception through completion.• Prepared all related court documentation during estate administration.• Prepared state and federal estate fiduciary tax returns.• Drafted estate planning documents for potential clients including Wills, Revocable and Irrevocable Trust Agreements, General and Health Care Powers of Attorney.• Assisted attorneys and clients with administration of trusts and guardianships.• Kept attorneys advised of filing dates and deadlines.

• Planned, organized, and coordinated all aspects of Department operations. Selected, trained, motivated and evaluated a staff of five (5) Paralegals and two (2) Administrative Secretaries.• Assisted shareholders (or their heirs) with mutual funds and corporations in recovering unclaimed assets.• Ensured that legal requirements for the transfer or sale of mutual funds and corporations shareholders’ securities were met.• Served as liaison with transfer agents who affect the transfer of mutual funds.

Prepared taxes for estates and trust accounts.Assisted Director of tax department in all secretarial areas.

Paralegal Certificate, Estates And Trusts

Bachelor Of Science, Political Science And Government