• Develop operational plans, manuals and charters for the trial• Review protocol and protocol amendments• Review the Investigator's Brochure (IB) from DevOps perspective• Review the Clinical Trial Application (CTA) submission package• Review Regulatory Green Light (RGL) packages in accordance with QDOC-08903• Review the Development Safety Update Report (DSUR)• Develop Global Master ICF• Follow up on Trial Oversight identified findings during Oversight until closure• Drives site selection in collaborate with Start-up• Oversee vendor management across vendors (does not include budget/change orders)• Approve key CRO staff e.g., Clinical leads, or Trial specific CRA• Conduct initial Protocol Deviation (PD) assessments and track trends• Ensure the ongoing completeness of the electronic Trial Master File (eTMF)• Collaborate or manage study escalations both internal & external• Support GCTM to Assess KPI/KQI at the trial level• Support QA in site audit activities and potentially vendor audits (supporting with trial information and collection and providing of relevant trial documents)• Conduct booster visits• Participate in inspection readiness activities as assigned• Oversee and collaborate with CTT members/vendors/assigned functional representatives on tracking and reconciliation of trial related items such as scans, blood samples etc.

• Development and review of PI/ICFs• Participate in Clinical Trial Management Team• Support Trial Related Documentation• Sponsor Oversight Activities (review of protocol, risk identification, assessment, and management, review monitor visit reports, development of trial oversight plan)• Perform Sponsor Oversight Visits• Ensure compliance with relevant regulations, Genmab SOPs and ICH GCP and Genmab Code of Ethics• Mentor Sponsor Oversight team members and support training in CTAs• Contribute to process optimization and SOP revisions• Lead and participate in cross-functional working groups/projects/task forces• Participate in audits/inspections and support development of responses to audit/inspection findings

• Development and review of PI/ICFs• Participate in Clinical Trial Management Team• Support Trial Related Documentation• Sponsor Oversight Activities (review of protocol, risk identification, assessment, and management, review monitor visit reports, development of trial oversight plan)• Perform Sponsor Oversight Visits• Ensure compliance with relevant regulations, Genmab SOPs and ICH GCP and Genmab Code of Ethics

Lead three global first in human phase I/II studies in US, UK, Spain, Germany, Netherlands and Denmark through start-up in both the escalation and expansion phases.• Manage clinical study start-up, maintenance and follow-up activities Control and coordinate effective operational management of the clinical team. Collaborate with study team to establish and develop integrated plans i.e. Clinical Monitoring Plan, support development of the risk management plan from a clinical perspective and coordinate clinical issue escalation and resolution.• Ensure alignment of clinical activities to budget, including identification of out of scope activities. • Understand the monitoring strategy required for the study and where required participates in the development of the study risk assessment plan. • Provide development and delivery of initial and ongoing training to the study team and plan and lead clinical study team calls to provide status updates.• Develop and execute corrective action plans at site and study level, proportionate to the risks identified. Utilize systems and tools to assess Key Risk Indicators (KRIs) and ensures that monitoring visits/calls are occurring in line with CMP/SMP. • Collaborate with other functional groups such as Data Management, Pharmacovigilance, vendors, and Biostatistics, where necessary, to support milestone achievement and to manage study issues and obstacles. ensure site compliance and delivery according to protocol, ICH/GCP and or Good Pharmacoepidemiology Practices (GPP) and country regulations, including medical monitoring, Safety, Quality Assurance (QA). Ensure Inspection Readiness for Clinical Scope.

• Utilized expert understanding of ICH guidelines to ensure compliance with regulatory bodies as well as ensuring all trials are conducted following Good Clinical Practice guidelines. • Oversaw clinical monitoring activities performed by CROs and clinical trial conduct by Investigators and their clinical trial staff with an emphasis on quality and compliance. • Collaborated with CROs to ensure smooth functioning of clinical trials. Maintained a comprehensive focus on safety and regulations to resolve issues and increase data quality and integrity as well as patient safety.• Work with DBV and CRO colleagues to support the completion of quality oversight tasks such as quality oversight visits, site visit report reviews, and the review and analysis of defined quality tolerance measures.• Established direct communication and close contact with Investigators and their clinical trial staff to facilitate site relationships for both the Sponsor and CRO. • Served as an escalation point for clinical monitoring issues for CRO monitors and site staff and provided guidance and coaching as needed. Escalated issues or defects encountered in the conduct of the trials to the appropriate contacts as needed. • Work with CRO management staff and/or the Director, Clinical Monitoring in resolving and escalating (when necessary) quality issues identified during the conduct of quality oversight activities.• Perform audit preparatory visits at the site level and participated in mock regulatory authority inspections in preparation for FDA inspections related to BLA submission. • Work with the Director, Clinical Monitoring to develop and/or improve the necessary skills to fulfill quality oversight responsibilities and assist in the development or improvement of quality oversight processes.

• Lead a global study in adjuvant breast cancer with 525 sites – 127 in US and Canada from startup to premature closure. • Manage clinical study start-up, maintenance and follow-up activities through ongoing tracking and review of study progress. Report progress to appropriate clinical management and project management teams. Control and coordinate effective operational management of the clinical team.• Managed the operational aspects of global oncology projects to meet contractual requirements. Collaborate with project leader and team to establish integrated plans to be accountable for results of the clinical team. Represent clinical delivery with customer. • Create and distributed status, tracking and financial reports for the project team, other functional groups and senior management. • Ensure appropriate subject recruitment plans are in place; all options are explored and deployed in consultation with the customer. Ensure patient recruitment target and contingency plans are in place and followed. • Deliver the project according to the quality management plan. Guide CRAs and advise on critical specific study issues. Drive high performance and efficiency of the clinical team through CRA project objectives and the conduct of monitoring visits. Provide performance feedback to management on clinical team members. • Develop the risk management plan from a clinical perspective and coordinate clinical issue escalation and resolution with the project leader. • Collaborate with other functional groups such as Global Delivery Network (GDN), Labs, Data Management, Pharmacovigilance, vendors, and Biostatistics, where necessary, to support milestone achievement and to manage study issues and obstacles. • Provide ongoing training and support to clinical team. Conduct frequent team meetings and communications. • Utilize appropriate clinical tools

• Clinical Site Manager for early development for Oncology with Amgen since July 2014Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.• Provide monitoring visits and site management for a variety of protocols phases Ib to IV, sites and therapeutic areas including rheumatoid arthritis, psoriasis, psoriatic arthritis, osteoporosis, diabetes, and oncology.• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager.• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans bysubmitting regular visit reports and other required study documentation.• Provide assistance to more less experienced clinical staff.Lead of the Mentoring initiative in the South Region training new mentors and mentoring new CRAs.Assist with national and regional meeting preparation and presentations.

• Collaborate with office staff to ensure test and procedures required by clinical protocols are performed and documented. These include but are not limited to, vital signs, EKG’s, drug administration and pharmacokinetic sampling.• Recognize adverse events and serious adverse events and promptly notify the appropriate parties.• Capture of data within electronic or paper case report forms in an efficient, accurate, and timely manner.• Serve as a contact person for ongoing clinical research studies and meet with representatives from sponsoring pharmaceutical firms or in-house staff for intial orientation to study and for review of study records.• Teach and mentor new employees, as directed, and provide feed back to Team Manager regarding new employee performance.• Review medical history and current medications, review protocol inclusion/exclusion criteria and confirm eligibility of subject.