Trial, Data, Project or Training Manager Resume

Desired Industry: Biotech	SpiderID: 15258
Desired Job Location: Loveland, Colorado	Date Posted: 9/2/2007
Type of Position: Full-Time Permanent	Availability Date:
Desired Wage:
	U.S. Work Authorization: Yes
Job Level: Management (Manager, Director)	Willing to Travel: Yes, Less Than 25%
Highest Degree Attained: MBA	Willing to Relocate: No

Objective:
Summary of Qualifications:

• 13+ years in the biotechnology industry
• 2 years commercial manufacturing experience as manager of the documentation group with 4 direct reports
• 11+ years of Clinical Data Management experience; Preclinical – Phase 3b/IV, EDC
• Effectively planned and lead the delivery and oversight of functional training programs for internal and outsourced personnel in classroom, one-on-one and electronic delivery environments
• Department trainer for Oracle Clinical, Brio Query, EDC (Medidata), and CRF (case report forms) design and identification of corresponding quality data audit checks
• Extensive experience managing Contract Research Organizations and other vendors
• Contract, Scope of Work and Request for Proposal reviewer
• Reviewed database design and integration of systems and provided appropriate consulting, interfacing, and training for the users
• Strong knowledge of GCP, GMP, FDA regulations and ICH guidelines
• Adept in Microsoft Word, Excel, PowerPoint; Six Sigma Yellow Belt
• Committed to a high level of ethical standards and discretion
• A talented early adopter who consistently achieves results within tight timelines and who operates successfully in cross functional teams
• Experienced in introducing new ideas and working practices, often implementing novel and innovative solutions
• Uses analytical and logical foundations with drive and persuasive reasoning to gain support and achieve desired business outcome within the framework of company policies

Experience:
2005 - Present Specialist, Manufacturing – Product Lifecycle Management Team, Manufacturing
Amgen Inc., Boulder, CO

• Responsible for coordination of the cross functional assessment of existing and potential product documentation requirements and managing their timely and exemplary execution as they impact the product life cycle
• Change champion for documentation process improvement initiatives and contributor to the defining and implementation of effective promotional activities in support of change initiation
• Translated strategic learning and development aims of the site into a diverse range of outreach communication and training offerings in support of compliance, learning, metric adherence, safety awareness and personal development
• Interface frequently with the executive site director and top site management
• Manager of four full time staff
• Subject Matter Expert for metric identification and optimal system collection

8/94 - 2005 Clinical Data Manager - Clinical Data Management, R&D
Amgen Inc., Thousand Oaks, CA
(Hired by Amgen Feb. 1996 from Select Temp Services)

• Lead data manager for 9 concurrent early development studies encompassing multiple therapeutic areas and study phases (pre-initiation, initiation, enrollment, duration, closure and shut down)
• Hyperlinking and QC of various studies for Amgen's first entirely electronic BLA
• Managed internal and outsourced personnel and vendors
• Authored and approved Data Management Plans and performed data review activities in accordance with the study protocol, SOPs, FDA and GCP Guidelines, and in conjunction with cross functional study plans to facilitate efficiency and consistency across all data management activities
• Contributor to forecasting, budget planning, assessing CDM resource requirements for current and future studies and staff reviews
• Training CDAs, CRAs and Biostatisticians in the use of Brio Query, relational and EDC database navigation, documentation and query writing and acted as a mentor to new staff
• Managed CRO deliverables for multiple outsourced trials: ensured accuracy and compliance with study protocol, budget, contract, SOW, data management plans and data transfer plans
• Webpage vendor liaison: conveyed publication expectations, negotiated timelines and budget information, edited page content, performed quality checks and evaluated graphics
• User Acceptance Testing and data review using Medidata's EDC tool
• Responsible for: negotiation, problem resolution, timeline adherence, quality deliverables, managing relationships, multi-project organization and knowledge of OC and SAS structures
• Implemented new department role of Assistant Clinical Data Associate
• Assisted in patient data review activities following departmental SOPs and DMP
• Maintained accurate, auditable documentation on all data management activities
• Creation and maintenance of CDM's Business Recovery Plan
• Contributed to the review and modification of Amgen Business Continuity software; increasing usability for clients and enhancing reports
• Promoted through multiple positions of increasing responsibility and visibility

Education:
2007
Master of Business Administration, concentration in Strategic Leadership
Will be complete in November 2007
Amberton University

2003
Bachelor of Science in Business Management
California Lutheran University

Affiliations:
Memberships:

Project Management Institute
Drug Information Association
Society for Clinical Data Management

Skills:
Computer Applications/Business Courses/Seminars & Workshops:

• Applications: Oracle Clinical (OC), MS Word, Excel, PowerPoint, Brio Query, SQL, Electronic Data Capture (EDC), Electronic Document Management (EDM)
• 21 CFR Part 11 & HIPAA training, FDA Sponsor Audit training, Accelerated Change Management Tools
• Currently studying for the Project Management Professional (PMP) credential
• Oncology preceptorship - Alta Bates Cancer Center
• Women in Business Leadership Forum – Los Angeles, CA

Candidate Contact Information:

Name: Tracy Wild Dachenhausen
Street: -	Phone: 805.217.9947
City: -	Fax: -
State: -
Zip: -
Web Site: