Dynamic Leader who offers a background in Project Management, Business Analysis / Planning, Client Development, Electronic Trial Operations (ETO), Global Statistical Programming, Risk Assessment, and Materials Development; contributes talents in Team Building / Training, Workflow Prioritization, Quality Assurance, and Regulatory Compliance; and exhibits an ability to see the big picture within evolving technological markets.

  Top Performer who can make sound decisions to reflect positively on project operations in alignment with a company s vision, value, and goals to attain a significant competitive advantage within deadline-driven timelines.

  Excellent Communicator who builds and sustained synergistic relationships with C-level executives, business / project / operational teams, internal staff, stakeholders, and clients to drive operations success.

Client Development Manager (2015 Present)

  Capitalize on the opportunity to direct forward-thinking account management of a key client, including delivering quality-focused ongoing relationship development and oversight of project- and business-related activities for the client, as well as leading process improvement efforts to ensure key quality and enhancements.

  Establish and manage client development standards and procedures.

  Direct global oversight of client satisfaction with Almac products and services.

  Identify and develop new service offerings that support the company s strategies.

  Partner with business development teams to secure and build relationships with new clients.

Senior Project Manager (2008 2012)

  Utilized broad scope of industry knowledge and dynamic business acumen toward delivering high-quality training and mentoring of top junior project managers on best practices, issues resolution, and career growth.

  Developed useful document templates (e.g. user reference guides, worksheets).

  Served as SME for client, including reviewing Requests for Proposals (RFPs) and advising client teams and project managers in comprehensive client standards, processes, and communication.

Project Manager (2006 2008)

  Strategically steered an internal project team and served as primary client contact in the development of customized IVR / IWR and drug supply management software, including integration with other systems (e.g. EDC and CTMS), as well as developing, implementation, and managing project timelines, deadlines, and deliverables.

  Created system-specific documentation to ensure that clients protocol-specific needs were accurately outlined and properly executed in the development of the software, including developing, validating, and providing ongoing support for initiatives that were performed in accordance with SOPs and industry-wide regulations.

  Maximized consistent communication and follow up for all client issues and / or concerns, including proactively working to mitigate challenges that could impact the comprehensive project process.

  Led project- and protocol-specific training and materials to project team members.

Yyyyyy x. yyyyyy ￨ Page Two ￨ (xxx-xxx-xxxx

Manager CDM Systems (Electronic Trial Operations)

  Spearheaded initiation, configuration, testing / validation, implementation, and maintenance of outsourced clinical systems (IVR/IWR), including integrations with CTMS, EDC, Clinical Supply Distribution System (CSDS), Biostatistics, and Biological Sample Management (BSM), including ensuring Electronic Trial Operations (ETO) systems met Amgen qualification expectations and manage project-related timelines and activities and deliverables.

  Cost-effectively procured resources, timelines, and services from both internal and external service providers, including serving as a technical expert and point of contact for cross-functional teams with stakeholders from global study management, biostatistics, clinical data management, supply chain, and additional clinical systems.

  Expertly reviewed and approved ETO providers documents.

  Actively identified and tracked study-related technical issues to resolution.

  Led feedback on clinical protocols related to electronic solutions and supported data standards use.

  Collaborated with provider project teams to manage expectations, communications, and negotiations.

Project Manager

  Optimized cardiovascular laboratory projects for multiple, complex international clinical trials by managing all facets of project efforts from study start-up through to closure, including ensuring successful design and implementation of project documents such as project management plan, study manuals, and central study files.

  Led targeted decision-making across 500 investigator sites, including effectively managing on-going core lab technical support, directing training on procedures and cardiac modalities, and resolving issues.

  Led sponsors protocol-specific training, including key guidelines and clinical data handling.

  Led a Gentiae Project Team in planning and executing the program and adhering to agreed-upon timelines, budgets, and quality standards which was instrumental in meeting or exceeding goals.

Quality Assurance Associate

  Played a vital role in conducting internal audits and ensuring strict compliance of clinical and laboratory studies to key global regulations, Good Manufacturing Procedures (GMP), and Good Documentation Practices (GPD).

  Performed verification of analytical, manufacturing, and clinical data in spreadsheets against raw data records.

  Successfully reported audit results and delivered solid recommendations to senior management.

  Recommended and followed up on corrective action plans per SOPs, policies, and global regulations.

Bachelor of Science in Biology (Emphasis in Biochemistry) Portland State University

Certified Scrum Master Scrum Alliance

Certificate in Clinical Trials Design & Management Xxxxxx State University

Date

Hiring Agent Name

Company Name

Address

City/State/Zip Code

Dear__________________:

I am seeking a challenging [ Insert Job Title ] role, and am submitting my resume for your review.

I am excited to build a rewarding career with your company, and can offer cross-functional experience in Project Management, Business Analysis / Planning, Client Development, Electronic Trial Operations (ETO), Global Statistical Programming, Risk Assessment, and Materials Development. I am also well-versed in Team Building / Training, Workflow Prioritization, Quality Assurance, Stakeholder Relations, and Regulatory Compliance, among other areas.

To complement my background, please note that I attained a Bachelor of Science in Biology with an emphasis in Biochemistry from Portland State University. I also hold Certified Scrum Master credentials from the Scrum Alliance and a Certificate in Clinical Trials Design & Management from Xxxxxx State University.

Currently, as a Client Development Manager for Almac Clinical Technologies, I expertly lead forward-thinking account management of a key client. Within this role, I successfully deliver quality-focused ongoing relationship development and oversight of project- and business-related activities for the client, as well as leading process improvement efforts to ensure key quality and enhancements.

During this time, I successfully:

  Establish and manage client development standards and procedures.

  Direct global oversight of client satisfaction with Almac products and services.

  Identify and develop new service offerings that support the company s strategies.

  Partner with business development teams to secure and build relationships with new clients.

[ Suggestion! Address Here Any Skills / Qualifications / Achievements Relevant to the Job Posting ]. As this is just an example of my abilities, please kindly refer to my enclosed resume for additional experience.

I look forward to hearing from you, and thank you in advance for your careful consideration.

Sincerely,

Yyyyyy x. yyyyyy