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Experienced Clinical Development leader with a demonstrated history of directing cross functional teams in the medical device and pharmaceutical industries. Skilled in both Pharmaceutical & Medical Device Project Management & oversite, Clinical Data Management, Site Selection and Vendor Management.
Acadia Pharmaceuticals Inc.
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Director, Clinical Operations - Therapeutic Area Lead, Rare DiseaseAcadia Pharmaceuticals Inc.Princeton, Nj, Us -
Associate Director Clinical OperationsCapstone Development Services Co, Llc Nov 2023 - PresentRosemont, Il, UsIn my role as Associate Director Clinical Operations at Capstone Development Services Co, LLC in Chicago, Illinois, I lead a cross-functional team on a novel orthopedic implant project. • Manage CRO and multiple vendors to timelines and contracts for successful project execution.• Develop study plans and procedures to ensure compliance with all laws and regulations. -
Sr. Clinical Project ManagerWorldwide Clinical Trials Jun 2023 - Nov 2023Research Triangle Park, Nc, Us• Lead core project team and facilitate their ability to lead extended/complete project team• Lead cross unit coordination both internal and external, inclusive of sub-contractors• Define and manage project resource needs and establish contingency plans for key resources• Ensure successful design, implementation, tracking and revision of project plans for assigned projects• Ensure project deliverables are met according to both WCT and client expectations• Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects• Act as key client contact for assigned projects• Establish excellent working relationships with client project teams and vendors to ensure client satisfaction and operational excellence.• Manage all aspects of designated projects -
Associate Director, Clinical Study ManagementAptinyx Inc. Dec 2020 - Mar 2023Directed the implementation and management of clinical research studies across multiple CNS Programs including chronic pain (fibromyalgia & diabetic peripheral neuropathy) and Parkinson’s Disease with mild cognitive impairment.• Strategized with the senior leadership team to overcome obstacles and develop long term development plans for compounds• Directed a team of Associate Clinical Study Managers and Clinical Study Managers, three direct reports, who led the internal and CRO study teams• Cultivated open communication and strong relationships with vendors to ensure transparency and open communication across organizations• Collaborated with Finance Team to develop and manage multiple study budgets in excess of $40M and participated in audits with external accounting firms, as required• Provided oversight for preparation of a diversity plan to increase and improve recruitment and enrollment of participants from underrepresented populations in projected phase three studies• Cooperatively developed a business case for the creation of Associate Clinical Study Manager roles to recruit and develop future Clinical Study Managers from a more diverse candidate pool
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Sr. Clinical Operations Study ManagerAptinyx Inc. Nov 2018 - Dec 2020Led the implementation and management of clinical research studies to quality standards, within proposed timelines, and on budget in accordance with clinical protocol and regulatory requirements.• Built industry leading partnership with CRO team and managed day-to-day communications and activities of the study team, including leading a change of CRO mid-study for non-performance• Guided study teams through a global pandemic, including pause and restart of studies and successful enrollment and completion of studies• Directed the coordination and management of activities of study execution including protocol development and feasibility, site selection, regulatory document collection, site initiation, site monitoring, data management, coordination of external parties such as steering committees, and site close-out in conformance to all relevant laws, regulations, guidelines and internal SOPs/policies• Utilized remote collection of data for critical study endpoints • Collaborated with CRO and other vendors to develop and implement risk management plans and centralized monitoring activities to ensure the quality of data to meet study endpoints• Led the vendor selection process and negotiation of agreement terms, ensuring deliverables, budgets, acceptance criteria and payment terms were clearly defined • Ensured effective tracking of study progress, data quality and vendor performance, based on pre-specified metrics• Founding member of the Aptinyx Community Team with a goal of improving Diversity, Equity and Inclusion in the workplace• In collaboration with internal stakeholders, ensured detailed study schedule and timelines were created in line with projected estimates, adjusting as needed
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Senior Manager, Clinical OperationsBaxter International Inc. Jul 2018 - Nov 2018Deerfield, Illinois, UsServed as strategic clinical development leader for one of Baxter’s largest global business units, Renal Care Services; supported Global Research & Development with operations across North America & LATAM. Directed protocol development, vendor selection and management, planning and resourcing staff and cross-functional team members. Provided coaching across all levels of the clinical development organization. • Managed both pre- and post-approval clinical studies for medical devices and pharmaceuticals designed to collect the required data to obtain PMA, 510K clearance or NDA acceptance and post-approval data to expand marketing opportunities and/or product claims including developing and maintaining the total study budgets• Managed a team of direct reports composed of clinical research associates, clinical trial associates, and clinical project managers• Consistently assigned to lead Baxter’s most challenging and rewarding top projects• Collaborated with and directed cross-functional teams, delivering clinical targets on-time, and ensuring clinical activities were conducted in accordance with Baxter procedures, ICH GCP Guidelines, and federal and international regulations • Distilled expertise from medical, engineering, quality, and technical service teams to solve complex problems • Navigated international business environments, system requirements, process mapping, and language barriers• Acted as a resource and mentor to facilitate onboarding of new clinical project managers and clinical research associates -
Manager, Clinical OperationsBaxter International Inc. Jul 2015 - Jul 2018Deerfield, Illinois, UsSelected to lead a cross-functional team for a top North American clinical study. Guided shut-down of project at termination and led development of final clinical study report for submission to FDA. Hired and trained new clinical research associates and developed new and revised SOPs to improve departmental efficiencies. • Facilitated preparation and development of clinical study protocols including aspects of study design, case report forms, and study specific procedures• Developed strategies and project plans to efficiently manage each project and maintain regulatory & legal compliance• Partnered with Diversity & Inclusion Team to become Co-President of the Baxter Equality Network, an employee resource goup, increasing membership from approximately 200 members to well over 1,000 advocates & members while expanding from one to six new chapters globally -
Lead, Senior Clinical Research AssociateBaxter International Inc. Jul 2012 - Jul 2015Deerfield, Illinois, UsTherapeutic area of focus: Home Hemodialysis & Human Factors Project ManagementIdentification and management of the necessary resources to successfully plan & complete Human Factors studiesDevelop strategies and project plans to efficiently manage each project and maintain regulatory & legal complianceIdentify necessary service providers and assess suitability of study location and facilitiesManage the day to day oversight of service providers, associated budgets, deliverables, timelines/milestonesConduct co-monitoring visits to evaluate the performance of field CRAsDevelop study specific forms and templates including paper and electronic CRFs, Product Issue/Product Complaint Forms, master Informed Consent Forms and templates, and other study specific procedures and logsDevelop and maintain tracking tools for study management including the Clinical Operations and Records Management PlansAssist with the set-up and management of CROs/complex partnershipsReview & approve monitoring and co-monitoring reports of field CRAsLead, plan and participate in project launch / Investigators' meetings Develop and negotiate site budgets with a value exceeding $5 millionRecruit, manage, and oversee clinical study vendors & multi-million dollar vendor contracts (central labs, e-diary solutions, home nursing care, & clinical lockers)Assemble, lead and direct cross-functional teams while creating agendas, action plans and meeting minutes for follow-up -
Senior Regional Clinical Research AssociateKeryx Biopharmaceuticals Jan 2011 - Jul 2012Therapeutic area of focus: Nephrology/Hemodialysis - Phase IIIManage all aspects of a clinical trial at all assigned clinical sites to ensure patient safety, adherence to appropriate safety regulations and data integrity Scientifically monitor clinical studies, which includes the review of case report forms and source documentation, to ensure adherence to the protocol, consistency, and scientific validity of the dataProvide full support, including technical and scientific guidance, to study site personnel to ensure consistency in interpretation and exchange of scientific informationDevelopment of study specific monitoring tools and other related documents (Monitoring Plan, Issues Document, & other study specific forms)Manage the query resolution process with sites, sponsor and company data management groupAssist study team with assessing study site feasibility and recruitmentPrepare for and conduct on-site qualification, study initiation, interim monitoring, and close-out monitoring visits at investigative sitesMaintain and review regulatory documents as requiredPrepare, attend and present information at project launch meetingsAssist the project team in the tracking of enrollment rates, receipt and review of completed CRFs to ensure the efficient execution of a clinical trial Assist in the preparation of documentation for submission to IRB/IECs
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Clinical Research Associate IiiMedpace, Inc Sep 2008 - Aug 2010Cincinnati, Oh, UsTherapeutic areas of focus: Type II Diabetes, Obesity, & Oncology Phases II - IIIManage all aspects of a clinical trial at all assigned clinical sites to ensure patient safety, adherence to appropriate safety regulations and data integrity Monitor clinical studies, which includes the review of case report forms and source documentation to ensure adherence to the protocol, consistency, and scientific validity of the dataProvide full support, including technical and scientific guidance, to study site personnel to ensure consistency in interpretation and exchange of scientific informationAssist the project team in development of study specific monitoring tools and other related documents as neededManage the query resolution process with sites, sponsor and company Data Management departmentsAssist study team with assessing study site feasibility and recruitmentPrepare for and conduct on-site qualification, study initiation, interim monitoring, and close-out monitoring visits at investigative sitesMaintain and review regulatory documents as requiredPrepare for and attend project launch meetingsAssist the project team in the tracking of enrollment rates, receipt and review of completed CRFs to ensure the efficient execution of a clinical trial Assist in the preparation of documentation for submission to IRB/IECs Prepare monitoring visit reports and contribute information for status reports for sponsorsAssist in the training of new CRAs via co-monitoring visits, role-play workshops, and review of site qualification and site study initiation presentations -
Pharmaceutical Sales SpecialistSepracor Inc Mar 2006 - Sep 2008Exceeded Q1 Quotas across all three products - March 2008Regional Council Representative - 2007 & 2008Conducted clinical peer training and certificationsDeveloped and implemented Total Office Call & Retail Pharmacy Call sales workshopsComputer Champion - Cincinnati District - 2006 & 2007 Facilitated training meetings and presentations to orient team members on data analysis tools and software updatesRepresented Sepracor at multiple medical conferences and professional meetingsRecognized for leadership & teamwork with multiple awards
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Sales RepresentativeTap Pharmaceuticals Inc Feb 2003 - Mar 2006UsSales Results 2005 & 2006: Exceeded market share and volume goals -
Emergency Room Technician/Telemetry TechnicianThe Community Hospital Oct 1991 - Jun 2003Plano, Tx, UsAssessed patient condition and implemented appropriate interventionsOrientation training staff - instructed new team members in proper use and care of medical equipment, procedures, and protocols -
Account ExecutiveIkon Office Solutions Apr 2002 - Feb 2003Exceeded all sales goals: 124% - 2002, 112% - 2003Managed existing accounts and prospected for new business through cold calling and telemarketing Developed and executed monthly marketing plans to drive new business -
Writing Across The Curriculum InstructorWright State University Sep 1999 - Jun 2001Dayton, Oh, UsProvided instruction to improve writing skills and graded assignments for all undergraduate levels Assisted in development and instruction of Anatomy and Physiology laboratory coursework -
Patient Care AssistantThe Children'S Medical Center May 1999 - May 2001Dallas, Tx, UsChildren's Urgent CareTriaged patient condition and implemented appropriate interventionsAssisted in orientation and training of new hires in clinical procedures and protocols
Dan Watson Skills
Dan Watson Education Details
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Wright State UniversityBiological Sciences -
Northwestern UniversityProject Management
Frequently Asked Questions about Dan Watson
What company does Dan Watson work for?
Dan Watson works for Acadia Pharmaceuticals Inc.
What is Dan Watson's role at the current company?
Dan Watson's current role is Director, Clinical Operations - Therapeutic Area Lead, Rare Disease.
What is Dan Watson's email address?
Dan Watson's email address is da****@****ter.com
What is Dan Watson's direct phone number?
Dan Watson's direct phone number is +193767*****
What schools did Dan Watson attend?
Dan Watson attended Wright State University, Northwestern University.
What are some of Dan Watson's interests?
Dan Watson has interest in Volleyball, Social Services, Children, New Technology, Chicago Bears, Project Management, Economic Empowerment, Education, Management Training, Photography.
What skills is Dan Watson known for?
Dan Watson has skills like Clinical Trials, Clinical Research, Pharmaceutical Industry, Oncology, Gcp, Cro, Medical Devices, Therapeutic Areas, Protocol, Clinical Monitoring, Clinical Development, Diabetes.
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