aktaPD’s® experts personify our action-oriented work ethics. These seasoned, vetted professionals, listed by category, are ready to leap into action for your next short-term or long-haul project. Their goal? To bring their vast knowledge, experience, and innovation to your team and leverage your resources and extend your capabilities so you can meet your goal.

Aleksander Chudnovsky, MD

CLINICAL RESEARCH & DEVELOPMENT PERSONAL PROFILE
  • 14 years in medicine and 9 years in academics and clinical research.
EXPERTISE Clinical Research; Genitourinary (GU) Oncology Clinical Trials, Medical Device Development Trials; Academic and Clinical Medicine; Medical and Legal Interpreting (Russian and Ukrainian); Specialties: Urology and Oncology (Prostate Cancer, ...
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Anders Tamsen, MD, PhD

MEDICAL & SAFETY MONITORING PERSONAL PROFILE
  • 40 years as a physician
  • 30 years in clinical trials for drug development
  • 20 years as medical/clinical entrepreneur
EXPERTISE Anesthesiology, Clinical Pharmacology, Surgery, Internal Medicine, Regulatory Affairs. Deep experience in regulatory affairs and project management including finding and contracting investigators and ...
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Angela Esteva

EVENT MANAGEMENT & PRODUCTIONS PERSONAL PROFILE
  • 15 years planning events and meetings
EXPERTISE Event Planning, Project Management, Sales & Marketing, Account Management. Classically trained in the European school of world class hospitality and in developing, motivating, managing, training, and leading diverse teams in short- and long-term corporate ...
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Annette Dubois

MEDICAL WRITER PERSONAL PROFILE
  • 17+ years in medical/regulatory/scientific writing and editing.
EXPERTISE Writing and Editing – Protocols, Protocol Amendments, Briefing Documents, International Regulatory Documents, Investigator Brochures, Safety Updates, Patient Narratives, Clinical Trial Reports, Statistical Analysis Plans, Funding Proposals, Articles, Manuscripts, and Conference Materials (brochures, posters, AV presentations, ...
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Anthony Kohut, RN

PHARMACOVIGILANCE & MANAGEMENT PERSONAL PROFILE
  • 15+ years in pharmacovigilance.
EXPERTISE International Pharmacovigiliance (Phases I-IV); Medical Specialties: Cardiovascular, Dermatology, Endocrinology, Gynecology, Hematology, Neurology, and Oncology; EDC Specialties: ARISg Safety System, DataFax, DATATRAK (Data System Blinded), Medidata Rave, and OmniComm; BSN/Registered Nurse. Associate Director of Pharmacovigilance, Pharm-Olam Overall responsibility ...
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Audrey Rossow

PROJECT MANAGEMENT PERSONAL PROFILE
  • 20+ years in clinical research, Phases I through IV primarily in US, and some in Canada, Iceland, and Eastern and Western Europe
EXPERTISE Project Management, Clinical Operations, Site Selection, Study Start-Up, Patient Recruitment, CRA, Trial Master Files, Investigators Meetings, Vendor Management, Training and ...
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Ayad Abdulahad, MB, ChB, PhD, MSc, MRCPath, FRCPath

MEDICAL DIRECTOR/MEDICAL AFFAIRS – CNS/ONCOLOGY/VIROLOGY PERSONAL PROFILE
  • 40+ years as a medical practitioner, 33 years in medical research, and 23 years in the pharma industry.
EXPERTISE CMO/Senior Medical Executive; Clinical/Protocol Development, Life Cycle Management, and Global Strategy of Therapeutic Agents; Global Medical Affairs; Statistics; Regulatory Affairs; Biotechnology; ...
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Bob Clay

REGULATORY AFFAIRS PERSONAL PROFILE
  • 30 years of experience in drug development across a diverse range of therapeutic areas and product types.
EXPERTISE Global Regulatory Affairs, Oncology and Infection, Neuroscience, Drug Development, Seasoned Executive, Strategic Thinking, Internal Change Management. PROFESSIONAL EXPERIENCE Vice President, Regulatory Affairs, Oncology and Infection, ...
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Bradley Tait, PhD

PROJECT MANAGEMENT PERSONAL PROFILE
  • Nearly 30 years in the science and pharma fields
EXPERTISE Scientist, Pharmaceutical Leadership, Project Management, Therapeutic and Technology Group Management, Pharmaceutical and Discovery Management (delivered 17 compounds in areas of Infectious Disease, Allergy Respiratory, Inflammation, Atherosclerosis, Cardiovascular, Cystic Fibrosis), Licensing, Portfolio Analysis, Restructuring, ...
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Cornelia Reininger, MD, PhD

ONCOLOGY, NEUROLOGY, CARDIOVASCULAR PERSONAL PROFILE
  • 14 years experience in pharmaceutical industry; 20+ years as a surgeon and intensive/emergency care physician.
EXPERTISE CMO; Design, Implementation, and Execution of Global Clinical Trials and Key Documents (Phases 1 to 3); Clinical/Regulatory Strategic Planning; Global Regulatory and IND/NDA Submissions (US, EU, ...
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Dr. Jacqueline Parkin, MBBS, FRCP, PhD

IMMUNOLOGY PERSONAL PROFILE
  • 34 years in medicine and clinical development
EXPERTISE Senior Level Clinical Development (first-in-man and translational studies through Phase 3 and regulatory filing); Adult/Pediatric Specialties: Immunological, Allergic, Metabolic, and Infectious Diseases; Expertise in: Biologics (including ‘high-risk; molecules), NCEs, Oligonucleotide, Stem Cell, and Gene Therapies, Immuno-Inflammatory Disorders ...
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Edward C. Dow, MD

HEMATOLOGY & ONCOLOGY PERSONAL PROFILE
  • 27 years as a Hematologist/Medical Oncologist, 20 years of clinical practice experience, and 3 years as a physician executive.
EXPERTISE Physician Executive, Medical Affairs, FDA Label Approvals, Oncology Genomic Profiling, Global Management in Oncology Therapeutics and Cancer Molecular Diagnostics, Clinical Studies Oversight, ...
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Erika Pelzer

Clinical Research, Program Operations PERSONAL PROFILE
  • 14+ years in project management, clinical operations, and clinical trials; 12+ years of team management.
EXPERTISE Drug Development; Clinical Trials Policy and Procedure Development; Database Creation and Management; Budget and Contract Development; Research and Medical Writing; CNS Neurology – Traumatic Brain ...
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Gary Maier, PhD

PHARMACOLOGY/CLINICAL DEVELOPMENT PERSONAL PROFILE
  • Over 30 years in clinical research field and pharmaceutical industry
EXPERTISE Scientist/Researcher, Senior Pharma Executive, Drug Development, Clinical Trials (IND - Phase IV), Early Clinical Research, PK/PD Analysis, Globalization of Clinical Pharmacology, FDA Interactions (INDs, NDAs, sNDAs), Contracts/Budget Management PhD in Pharmaceutical Sciences ...
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Gema Gomez

PROJECT MANAGEMENT PERSONAL PROFILE
  • 27 years in clinical project management and innovation.
EXPERTISE Clinical Project Management, Innovation, and Technology; SOP Development; Process Improvement; Vendor Selection and Management; Early-Stage and Post-Marketing Global Clinical Development; Large-Scale Global Phase II-IV Pharmaceutical Studies; Relationship-Building and Management; Training Development and Facilitation; Public Speaking ...
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George Naumov, PhD

ONCOLOGY: RESEARCH & LEADERSHIP PERSONAL PROFILE
  • 15+ years of professional experience as a scientist and executive working in oncology.
EXPERTISE Scientist/Researcher, Oncology Specialty, Start-ups, Angel Investment/VC, Business Development and Strategy, Management Consultant. PROFESSIONAL EXPERIENCE Management Consultant, DavCard Group and MedPharma Partners Provide advisory services to VC portfolio ...
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Helena Champion, MS, MBA

COMPLIANCE/QUALITY SYSTEMS SPECIALIST PERSONAL PROFILE
  • 25 years of US and international experience in pharmaceutical and biotechnology manufacturing and testing, medical devices, and product development.
EXPERTISE Quality and Regulatory Compliance Support for Pharmaceuticals, Medical Devices, and Chemical Reagents; Audits; Supplier Qualification; Optimization of Contract Manufacturers, Testing Laboratories, and Suppliers; ...
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Inder Kaul, MD, MBBS, MPH

MEDICAL EXECUTIVE, CLINICAL DEVELOPMENT PERSONAL PROFILE
  • 20+ years as a pharma executive, 27+ years in clinical development, and 30+ years as a physician.
EXPERTISE CMO; Clinical Development (drugs, biologics, and medical devices); Global Clinical Trials (Phases 1 – 4); Product Registration and Post-Marketing Activities; Project Management of INDs, ...
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James Bolognese, M.Sc.

BIOSTATISTICIAN PERSONAL PROFILE
  • 40 years in life sciences as a biostatistician
EXPERTISE Biostatistician; Statistical Analysis; Clinical Development Program and Trial Design; Adaptive Designs and Implementation; Statistical Support of Biomarker Development; Technical Oversight/Guidance of Statistical Analysis Vendors; Software Design, Development, Testing, and Refinement. Authored nearly 100 peer-reviewed publications and ...
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Jamie Blackburn

eLEARNING / KNOWLEDGE TRANSFER PERSONAL PROFILE
  • 25 years in F100 and Life Sciences Information Technology
EXPERTISE Project Management, Six Sigma, Systems Integration, Technical Architecture and Custom Software Development. Senior leader with proven ability to drive projects successfully and to collaborate with a wide variety of people in ...
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JD Bernardy

REGULATORY AFFAIRS PERSONAL PROFILE
  • 30 years of experience in domestic and international pharmaceutical and medical device industry.
EXPERTISE Regulatory Affairs, Clinical and Quality Assurance/Compliance and Operations Systems, GCP Compliance, Project Management, Investigational (IND, IDE, CTA, CA, and EC submissions) and Marketing Applications (NDA, BLA, and PMA; MAA ...
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Jeana Burt

CLINICAL OPERATIONS SUPPORT / TRIAL ASSISTANT PERSONAL PROFILE
  • 11 years in clinical operations support.
EXPERTISE Operations Management, Information Systems Management, Regulatory Affairs Management, Fiscal Management, Clinical Trial Assistant (cardiology, dermatology, device, gynecology, gastroenterology, oncology/hematology, urology), Process Analyst, Data Flow Analysis and Documentation of US Clinical Trial Process, ...
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Joel Hale

CLINICAL RESEARCH / CLINICAL OPERATIONS PERSONAL PROFILE
  • 23+ years of clinical research experience.
EXPERTISE Clinical Trial Design, Implementation, and Management; Clinical Operations; Clinical Research; Monitoring; Site Development; Clinical/Regulatory Guidance; Study Lead; Project Management; Writing- Protocols, SOPs, CRFs, Business Plans, Budgets, Operational Timelines, and Mission Statements; Investigator/Coordinator Training ...
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John Bradford

PRODUCTIONS & MARKETING PERSONAL PROFILE
  • 25 years in production and project management of meetings and special events, specializing in pharmaceutical, corporate and technological industries
EXPERTISE Project Timeline Creation, Workflow Scheduling, Budget Development, Administration and Reconciliation, Meeting Theme Branding. PROFESSIONAL EXPERIENCE Director, Productions – The Right Plan (TRP) ...
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John Patrick Hanrahan, MD, MPH, FCCP

RESPIRATORY / IMMUNOLOGY & REGULATORY AFFAIRS PERSONAL PROFILE
  • 15 years as a research/clinical development physician in the pharma industry.
  • 30 years in medicine.
EXPERTISE Physician Executive, Global Drug Development, Chief Medical Officer, Clinical Research, Clinical Trials Design and Implementation, Principle Investigator, Rare and Orphan Indications, International Regulatory Affairs/Filings, ...
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Kimberly Potts

PROJECT MANAGER PERSONAL PROFILE More than 20 years of diversified experience in the administrative and customer service fields. EXPERTISE Project Management, Data Research and Compilation, Query Testing, Global Transparency Reports, Customer and Financial Reports (CTMS data validation), Sponsor Liaison, Sponsor Documentation (files, records, and reports), File Review and Audit, ...
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Larry Yarmaloff, CCRA, RQAP-GCP

PROJECT MANAGEMENT / CLINICAL OPERATIONS & DEVELOPMENT PERSONAL PROFILE
  • 24 years in clinical development of investigational therapeutic and diagnostic products.
EXPERTISE Clinical Operations; Monitoring; Clinical Research Line Management; Domestic and International Phase 1-4 Pharmaceutical Studies and Pilot, Pivotal, and Post-market Medical Device Studies; Investigational Site Feasibility and ...
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Leonard Mattano Jr, MD

HEMATOLOGY/ONCOLOGY PERSONAL PROFILE
  • 30 years in medicine and the pharmaceutical industry.
EXPERTISE Pharma Executive; Hematology/Oncology Drug Development (Hematologic Malignancies, Sarcomas, Brain Tumors, Melanoma, Pediatric Cancer, and Hematologic Disorders); Academic Clinical Trial Strategy, Design, Management, Monitoring, Compliance, Reporting and Publication; Pediatric Hematology/Oncology; Global Regulatory; Administration; Management; Portfolio Global Strategy: ...
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Lindsey Lozano

MEDICAL WRITER PERSONAL PROFILE
  • 11 years in medical writing, specializing in medical/pharmaceutical/scientific drafting and editing.
EXPERTISE Writing – Protocols, Investigator Brochures, Annual Reports, Investigational New Drug (IND) Application Sections, Marketing Applications, Briefing Documents, Regulatory Meeting Slide Decks, Publications, Clinical Study Reports; Document Formatting and QC; Project Management ...
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Lou Vaickus, MD, FACP

FOUNDER & PRESIDENT PERSONAL PROFILE
  • 30 years in medicine and the pharmaceutical industry
  • 15 years of executive pharma leadership
EXPERTISE Physician Executive, Executive Leadership, Clinical Development & Medical Affairs, Preclinical Development, Regulatory Affairs/Quality Assurance, Business Development/Fundraising, Commercial Marketing, Medical Writing/Communications, C-suite Activities. Extensive experience at start-up small-, ...
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Lynn B. Sutton

CLINICAL OPERATIONS PERSONAL PROFILE
  • 30 years in medical and pharmaceutical arenas.
EXPERTISE Cost Management, Process Improvement, Functional and Operational Efficiency, Strategic and Development Planning, Vendor Evaluation, Third Party and R&D Integration, Gap Analysis, Collaboration/Accountability/Decision-Making, CRO Partner Management. PROFESSIONAL EXPERIENCE Founder and Principal, Professional Clinical Consultants, LLC Provides ...
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Marc S. Rudoltz, MD

ONCOLOGY CLINICAL DEVELOPMENT PERSONAL PROFILE
  • More than 26 years in radiation oncology
  • 13 years in pharma industry oncology clinical development
EXPERTISE Practicing Radiation Oncologist, Oncology Clinical Trials (Phases I-IV), Chief Medical Officer, Global Clinical Development, Research (academic and pharma), Regulatory Filings, Commercialization, Strategic Decision-Making and Operational Processes, ...
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Mary-Anne McKenna, M.Ed.

CLINICAL OPERATIONS PERSONAL PROFILE
  • 16 years, mostly in clinical operations.
EXPERTISE Clinical Trials; Compliance; Protocol Synopsis/Development; Project Budgets and Timelines; Management of Field CRAs and Internal Project Coordinators; Vendor Selection, Oversight, and Audit (CROs, labs, imaging, drug distribution); Patient Recruitment and Retention; SAEs and Regulatory Reporting; Site ...
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Melanie Raskin

STAFF WRITER PERSONAL PROFILE
  • 33 years in the communications field, specializing in medical/pharmaceutical, health/wellness, and state government/public interest.
EXPERTISE Writing - Video, Audio, Print, Web/e-, and PR/Marketing; Communications Project Management; Video and Audio Producing/Directing; Client Relations/Sales and Expectations Management; KOL/Patient/Clinician Interviewing; Copy Editing; Creative Brainstorming; Storytelling and Audience ...
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Oscar Laskin, MD

RESPIRATORY & ONCOLOGY PERSONAL PROFILE
  • 27 years of drug development experience in large and small pharma companies.
  • 36 years in medical/research field.
EXPERTISE Physician Scientist, Medical Executive, Translational Medicine, Academic Clinical Investigator, Clinical Pharmacology, Drug Development, Clinical Trials, Oncologics, Biologics, Chief Medical Officer, Global Management, Regulatory, Advisory ...
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Oscar Segurado, MD, PhD

ONCOLOGY/INFLAMMATION/GENOMICS PERSONAL PROFILE
  • 30+ years in global clinical development, medical affairs and translational research.
EXPERTISE HIGHLIGHTS Global Clinical Development of Drugs/Devices/Diagnostics; Global Clinical Operations (registration, launch, post-launch, and study publications); Pharma Executive; Scientific and Industry Experience in Rheumatology/Autoimmune/Inflammatory Diseases, Oncology, and Hematology; Compliance, QA and Regulatory; Tenured ...
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Parker Ress

GRAPHIC DESIGNER PERSONAL PROFILE
  • 15 years as a data-driven graphic design expert in a broad range of industries including pharma, manufacturing, military, and higher education.
EXPERTISE Presentation Design, Poster Design, Branding, Marketing Materials, Visualizing and Simplifying Complex Concepts. PROFESSIONAL EXPERIENCE Virtual Apiary, Inc. – Owner/Graphic Designer Specializes ...
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Patti L. Arsenault, MBA

DATA MANAGER PERSONAL PROFILE
  • 20 years in data management.
EXPERTISE Clinical Data Management, Database Developer, EDC/Site Vendor Selection and Management, Process Improvement, SOP Development, Internal Data and Sponsor Audits, Data/Vendor Management Plans, Case Report Form Authoring/Library, Protocol Violation Reporting, Adverse Event Management, Proposal Writing, GCP, ICH, and ...
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Philip Gregory Janicak, MD

PSYCHIATRIC CLINICAL TRIALS PERSONAL PROFILE
  • Nearly 40 years in the psychiatric medicine field
EXPERTISE Mood and Psychotic Disorders; Research Psychiatry; Therapeutic Neuromodulation ECT (electroconvulsive therapy) and TCM (transcranial magnetic stimulation); Psychiatric Drug Development (psychosis and depression); Clinical Trials; Management and Treatment of Schizophrenia, Depression and Bipolar; Psychopharmacology; ...
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Rachel Harrigan, MD

LEADERSHIP / CLINICAL DEVELOPMENT PERSONAL PROFILE
  • 29 years in drug development.
EXPERTISE CMO, Operational Oversight, Strategic Planning & Development, Clinical Development and Medical Oversight, Negotiating and Influencing, Team Leader, Line Manager, Team-Building, and Engagement. PROFESSIONAL EXPERIENCE Pharmaceutical Consultant, Harrigan Consulting, LLC Strategic review partner for venture investors in ...
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Robert Mulrooney, MB, BCh, BAO

COMMERCIAL/MEDICAL STRATEGY PERSONAL PROFILE
  • 24 years in pharma medical management/leadership and commercialization strategies.
EXPERTISE Global Medical Leadership, Strategy and Operations, Commercial Assessment, In-Licensing, R&D, Medical Affairs, Marketing and Sales, Business Development, Change Management, Physician, Specialties: Small Molecules/Biopharmaceuticals, Hospital Internal Medicine, Cardiology, Immunology/Inflammation, Ophthalmology, Cardiovascular Diseases, Diabetes Mellitus, ...
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Sandra Chica, MD

ONCOLOGY, CLINICAL DEVELOPMENT, IMAGING PERSONAL PROFILE
  • 15 years of pharmaceutical industry and clinical research experience.
EXPERTISE Clinical Development, Imaging, and Research (oncology, small molecules, biologics, medical devices, and diagnostics); Clinical Development Plans; Scientific, Medical, and Operational Leadership of Clinical Trials (all phases); Clinical and Regulatory Strategy; Protocol ...
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Scott Chase

COMPLIANCE, QA, & REGULATORY AFFAIRS PERSONAL PROFILE
  • 13 years in the compliance field.
EXPERTISE Developing Quality Systems; Part 11 Compliance (back and front end, software and hardware); Validation (process and equipment); Foreign CMO Oversight and Batch Record Review (France, Italy, Germany); GLP Studies (PK and Tox, rodents/primates); ...
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Sheree Mann

OPERATIONS, MARKETING & SALES PERSONAL PROFILE
  • 18 years in pharmaceutical field
  • 10 years of business ownership in marketing, production planning, branding and web design
EXPERTISE Budget Oversight, Contract Negotiations, Strategic Planning, Project Management, Marketing, Operations, Entrepreneurial Attitude & Agility; Relationship Broker. PROFESSIONAL EXPERIENCE Chief Operating Officer, Marketing, ...
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Terrie Blalock

KOL & ENGAGEMENT AND MARKETING EXPOSURE PERSONAL PROFILE
  • 30 years in medical and pharmaceutical arenas
EXPERTISE Site and Patient Management, Key Opinion Leader (KOL) Development, Establishing Relationships, Competitive Intelligence, Patient Advocacy Groups and Professional Societies, Negotiations, Strategic Planning/Analysis. PROFESSIONAL EXPERIENCE Director, Medical and Professional Services – Merz ...
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Tracy Wild Dachenhausen, MBA, CCDM

DATABASE MANAGER PERSONAL PROFILE
  • 21 years in database management.
EXPERTISE Certified Clinical Data Management Professional; Oncology; Project Management; CRO and Vendor Management; Process Improvements; SOP Development; Data/Vendor Management Plans; Standards Creation and Management; Contracts and Financial Analytics; Process Improvement; GCP, ICH, and GMP Compliance; Cross-Departmental Trainer of ...
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