Jen Ohme, Mba,Pmp,Csm Email & Phone Number

Washington Dc-Baltimore Area

Serve as a senior advisor and advocate for supported service lines within IQVIA and externally.Design, architect, and lead delivery of new technologies to support our connected devices service linesEvaluate probability of risks and their impact, develop and implement quality and risk management plans for minimizing impact on Service Line development activities.

Durham, Nc (Remote)

Manage Cardiac Safety Services-Connected Device projects for multiple pharmaceutical clinical trials. Co-Lead the Actigraphy service line and work to expand service offerings and scope of support for those new services. Researching and selecting new actigraphy devices and vendors to build actigraphy product line and working directly with actigraphy vendors on implementing and evaluating project processes.• Responsible for managing all phases of client Cardiac Safety Services-Connected Devices projects.• Select and work with Actigraphy vendors as Co-Actigraphy Service Line Lead.• Maintain quality control of the data, project deliverable and closeouts.• Conduct virtual and in-person training sessions to ensure trials teams are effectively trained on product and data collection responsibilities.

Tempe, Arizona (Remote)

Managed IRT services profit and performance. Presented IRT service offerings via prospective client presentations, demonstrations and contributed to bid defense meetings. Reviewed RFPs to provide IRT solution recommendations.• Actively managed 25+ different IRT projects in differing phases of the SDLC lifecycle on-time and within budget. • Designed, maintained, and updated IRT Standard Operating Procedures (SOPs) and work instructions, including template IRT user requirements specification, management plans, test plans, and training guides for each IRT product.• Directly responsible for managing all phases of client IRT projects, including selecting and managing IRT vendors and validating in-house products and vendor offerings.• Oversaw validation and fit-for-use initiatives for SaaS products used in various IRT projects.

Tempe, Az

Managed IRT project lifecycle from start-up to closeout. • Responsible for managing all phases of client IRT projects.• Selected and performed IRT vendor management for projects not able to utilize our SaaS products.• Built IRT Demonstration database and was responsible for conducting IRT demonstrations for potential clients. • Maintained quality control of the data, project deliverable and closeouts.• Conducted industry presentations, including Understanding Patient Randomization and the Role of IRT in Clinical Trials (August 2017 Webinar) and Inventory and Randomization Functionality Overview (May 2018 iMedNet User Group Meeting).

Baltimore, Md

Responsible for the Product Development release process, including managing the sprint daily stand-up, planning, and retrospective meetings. Owner of the Product Backlog and leader of the backlog prioritization meetings. Accountable for developing Product User Requirement Documentation. Participant in potential Client meetings, including drafting the meeting content, conducting the application demonstrations, and assisting in RFIs. Member of the corporate Quality Assurance team.• Set-up Microsoft’s Team Foundation Server (TFS) for Product Sprints, which has resulted in increased development resource utilization and Product Backlog transparency.• Lead a new Product application release, providing a configurable solution with shorter implementation timelines for potential clients.• Developed Client related project materials for the new Product application, including project Implementation plans, configuration requirement checklists, and training documentation.

Rockville, Md

Ensured research goals and project deliverables were met according to study timelines and in accordance with ICH GCP Guidelines, applicable regulations, and Emmes quality standards. Responsible for planning, communicating, and delivering project deliverables for both new and existing projects under the Vaccine and Infectious Disease (VID) contract. Provided leadership to the internal Data Management/Protocol Monitoring project team managing multiple vaccine trials, and facilitated communication between internal and external project collaborators.

Minnetonka, Mn

Directed project management, technical product support and customer service as it related to client project delivery, training and overall customer satisfaction in utilization of MedNet products for clinical trials. As part of senior leadership, participated in strategic decision making in setting and achieving corporate and operational goals. Worked closely with Business Development in pre and post-sale process ensuring successful understanding and implementation of Client requirements and expectations.

Minnetonka, Mn

Lead project management and customer service teams responsible for project delivery, training, customer support and project maintenance. Directed internal work flow by assigning resources, priorities, and facilitating communication between project management and technical development in delivery of client projects following a Software Development Life Cycle (SDLC). In conjunction with Quality Assurance (QA) team, oversaw implementation and ongoing progress of continuous quality improvement, including development, review and updates to Standard Operating Procedures (SOPs), work Instructions (WIs) and templates.• Hired, trained and mentored project team members, resulting in a 20 person department actively managing 85 projects/year including Investigator Initiated Trial (IIT) websites, while personally managing 6-8 projects/year.• Managed 34 projects in varying complexity and clinical trial phases for multiple medical device, pharmaceutical and Contract Research Organization (CRO) companies, with 100% client satisfaction and 75% repeat business ratings.

Minnetonka, Mn

Maintain day-to-day coordination with project team to deliver a quality product to the sponsor. Developed and maintained project documentation; including specifications, communication plans, meeting agendas and minutes, test plans and results, and training materials. Coordinated and participated in functional testing, and managed client user acceptance testing (UAT). Lead team reviews after each project milestone, adjusted schedule and deliverables, drove continuous improvement. Delivered projects live on time, within scope and budget, through critical and creative decision making for time-sensitive projects. Followed project SOPs, ICH GCP Guidelines and other applicable regulations. Trained customers on project website functionality and reporting tools, either via ‘Go to Mtgs’ or Investigator Meetings. Provided site support to clinical investigators and study coordinators.• Creatively worked to meet clients critical timeline requirements by implementing phased project releases, allowing clients to begin site start-up, patient enrollment and/or patient randomization within specified timelines prior to full project ‘go live’.• Successfully managed the largest Head and Neck Cancer Registry to date, which has produced 20+ abstracts and posters.• Developed and directed new customer service department, including creation of customer contact management system. • Hired, trained and managed customer resource specialist team members.

Minnetonka, Mn

Edina, Mn

Owned operational effectiveness of claims team. Coached and developed staff.

Edina, Mn

Attained pertinent information in order to determine eligibility and manage claims. Listened to claimants, policy holders, and doctors, while communicating expectations.

Masters, Mba

Activities and Societies: Mayo Innovations Scholars Program

Ba

Activities and Societies: University of Minnesota Chapter Phi Beta Kappa Honor Society

Education record

Activities and Societies: GTE Academic All-American District Team, Captain 4 years for Bemidji State University Women’s basketball team.

Education record