Daniel Obando Email & Phone Number

Cambridge, Cambridgeshire, Gb

Sydney, Nsw, Au

Responsible for the planning and management of all contracted responsibilities for assigned clinical projects. Act as primary contact between Novotech and client. Ensure that clinical trials are conducted according to ICH GCP guidelines, local regulatory requirements, Novotech/client SOPs and the Project Agreement. Lead the internal Novotech project team, including sub-contractors. Responsible for project budget and revenues.

Sydney, Nsw, Au

Responsible for the planning and management of all contracted responsibilities for assigned clinical projects. Act as primary contact between Novotech and client. Ensure that clinical trials are conducted according to ICH GCP guidelines, local regulatory requirements, Novotech/client SOPs and the Project Agreement. Lead the internal Novotech project team, including sub-contractors. Responsible for project budget and revenues.

Sydney, Nsw, Au

Provides project leadership as the primary liaison between the Company and the Customer to ensure study start-up, conduct, and closeout according to the Customer’s and the Company’s contractual agreement, and in accordance with SOPs and applicable regulationsAt the same time having a leadership role within Clinical Operations department. - Project Leadership: primary study lead, worked directly with customer to ensure all study deliverables were met under agreed timelines. Primary contact to study external stakeholders. - Project Leadership: directly managed all internal stakeholders (i.e. DM, Stats, Clinical Operations and Medical Writing teams) to ensure project related tasks and/or issues were addressed and completed per agreed timelines. - Business Development: developed strong relationships with customers to generate new and/or add-on future business, leading to repeat-work. Supported the Business Development in various activities (i.e. proposal development, bid defenses). - Mentoring/Coaching: provided extensive and continuous training, mentoring and coaching to all Clinical Operations members. Especially junior members of the department. - Knowledge/Training: demonstrated knowledge of current therapeutic environment and drug development trends. Facilitated team training in accordance with protocol and/or project requirements including therapeutic, protocol specific and process training.- Communication: effective communication with the customer and project team through oral and written correspondence, status reports, and monthly progress reports, and customer presentations. - Finance: managed the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses. Performed ongoing review of project financial status of studies within my responsibility. Alerted senior management of potential issues and ensured necessary corrective action were taken.

Switzerland 🇨🇭 , Ch

Provides leadership and regional/local strategic planning and operational delivery of assigned clinical studies through all phases of study management (preparation, start-up, conduct, close-out), in accordance with Roche quality standards, all applicable regulations, timelines and budget commitments- Project Leadership: successfully managed clinical studies as member of the global management team. - Project Leadership: successfully managed all assigned studies throughout different stages. Managed and maintained accurate country/study level plans (e.g. timelines, budget, resource, risk and quality plans).- Mentoring/Coaching: provided support and leadership to responsible study team members. At the same time coached and mentored junior members of my team or department. - Collaboration: have developed and maintained good site relationships with key investigator sites, alliance partners and/or collaborative groups. Participated in different study Therapeutic Area support/meetings with therapeutic leads and country experts. - Medical Affairs: have successfully worked alongside Medical Managers to improve the overall trial deliverables and product development. - Finance: Managed the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses. Performed ongoing review of project financial status. - Study Management: study feasibilities, site monitoring performance, developed Risk Based Monitoring plans (including Trial Monitoring Plans), TMF completeness and oversight of all relevant compliance activities for allocated studies.

Raleigh, North Carolina, Us

Provides project leadership as the study lead and primary liaison between the Company and the Customer to ensure study launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement, and in accordance with SOPs and applicable regulations- Project Leadership: primary study lead, worked directly with customer to ensure all study deliverables were met under agreed timelines. Directly managed all internal stakeholders (i.e. DM, Stats, Clinical Operations and Medical Writing teams) to ensure project related tasks and/or issues were addressed and completed per agreed timelines.- Business Development: developed strong relationships with customers to generate new and/or add-on future business, leading to various repeat-work. Supported the Business Development in various activities (i.e. proposal development, bid defenses). - Mentoring/Coaching: mentored and coached various team members, in particular two colleagues that under my mentorship/coaching went from Project Assistant to Project Manager. - Finance: managed the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses. Performed ongoing review of project financial status of studies within my responsibility. Alerted senior management of potential issues and ensured necessary corrective action were taken. - Communication: effective and transparent communication with the customer and project team.

Raleigh, North Carolina, Us

Work in conjunction with project management staff to assist with implementation of programs and studies. This includes coordinating study activities and assisting with measurable project deliverables and goals- Project Administration: tracked and processed clinical trial information; such as regulatory & ethics documents, enrolment, safety information, protocol deviations, supplies, data queries and others. - Project Leadership: Served as primary customer contact when project managers (PM) were out of the office (on various occasions). - Finance: supported the assigned PM in various finance and tracking activities. - Essential Documents: created various study documents, such as Informed Consent Forms (ICFs) and performed Case Report Form (CRF) review. - Communication: Attended various study meetings, prepared and distributed all meetings minutes and follow up on important actions items.

To oversee and assist in the oversight of the conduct of clinical study(ies) in accordance with the protocol(s), project plans, ICH-GCP, applicable regulations and company SOPs to ensure the delivery of timely and accurate data within budget - Monitoring: on-site monitoring and remote monitoring for oncology clinical studies. Conducted various site activations, monitoring and closeout activities, audit activities (only minor findings) and data management assistance. - Start-Up: ethics and regulatory submissions for various studies. - Collaboration: builded positive relationships with internal (i.e. lead clinician, study chair, Stats) and external (i.e. PIs, study coordinators and various vendors) to ensure all issues or risks were appropriately addressed - reflecting reliable data and study protocol compliance.- Document Development: developed study documentation and materials, such as ‘site data management manual’ and various study progress reports for internal and external meetings.- Finance: worked with finance to generate customer/vendor invoices. Managed site payments.

The University Of Sydney, New South Wales, Au

- Research Experience: extensive experience in organic and medicinal chemistry research (drug discovery and lead optimization). - Communication: presented two oral presentations at International Conferences and many internal and extra-departmental oral presentations. Also presented various poster presentations at local and International Conferences. - Teaching: involved in teaching (lectures), organization and general academic tasks for the School of Pharmacology.- Scientific Writing: prepared research experimental data and wrote sections of 3 scientific papers. At the same time was co-author on a scientific review paper.- Collaboration: developed various research networks and collaborations within the University of Sydney and other Australian and global universities/research institutes.- Mentoring: trained and mentored 5 research students in different research projects.- Preclinical Research: conducted various in vitro and in vivo studies.

Gradute Diploma - Drug Development, Discovery, Development And Marketing Of Pharmaceuticals

Doctor Of Philosophy (Ph.D.), Medicinal And Pharmaceutical Chemistry