Candidate Information Name Available: Register for Free Title Clinical Trial Manager, Clinical Trial Coordinator, Clin Trial L Target Location US-NC-Wake Forest	20,000+ Fresh Resumes Monthly     View Phone Numbers     Receive Resume E-mail Alerts     Post Jobs Free     Link your Free Jobs Page     ... and much more Register on Jobvertise Free
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SUMMARY OF EXPERIENCESenior operations leader with expertise in all phases of global drug development, clinical trial conduct, site/vendor management, maintenance of timelines/budgets, inspection readiness, GCP auditing and consulting.THERAPEUTIC EXPERTISEGene TherapyCandidate's Name
Neurodegenerative DiseaseAsthmaRare DiseaseRenal DiseaseTransplantation/ImmunologyCV DiseaseINDEPENDENT CONSULTING:Civitas Therapeutics, Inc., Chelsea, MAFebruary 2013  July 2015Alnylam Pharmaceuticals, Inc., Cambridge MAJuly 2013  July 2015Clementia Pharmaceuticals, Inc., Dorval, Quebec, CanadaJuly 2015  July 2016Allena Pharmaceuticals, Newton Lower Falls, MAJuly 2015  October 2016Infinity / Verastem Pharmaceuticals, Needham, MANovember 2016  March 2017Voyager Therapeutics, Inc., Cambridge, MAApril 2017  July 2019Asceneuron SA, Lausanne, SwitzerlandJuly 2019  October 2020Talaris Therapeutics, Inc., Wellesley, MANovember 2020 May 2021Asceneuron SA, Lausanne, SwitzerlandMay 2021 September 2021Pulmatrix, Inc., Lexington, MAJanuary 2022April 2022AVROBIO, Inc., Cambridge, MAApril 2022October 2022Vendor compliance audit (confidential), San Diego, CADecember2022February2023Verge Genomics, South San Francisco, CASeptember2023May 2024Develop RFPs (Requests for Proposals) for Phase I - III Clinical Programs.Analyze RFP proposals/organize Bid Defense meetings.Develop clinical budgets for Phase I  III clinical programs.Solicit/select/negotiate/manage vendor contracts for Phase I  III clinical programs.Manage study start-up activities, timelines/deliverables, close out with final reconciliation.Review/edit study documentation provided by CRO and clinical sites with respect to protocol adherence and GCP compliance.Review/edit study manuals/plans for content and user friendliness (Manual of Operations, Monitoring Plan, Project Management Plan, Communication Plan, etc.)Create study specific documents in accordance with protocol specifications.Review eCRFs (i.e., Medidata Rave), DVSs and perform UAT as required.Conduct clinical site audits, pre-inspection audits, provide site and CRO training as required.Manage global ISL distribution processes in collaboration with PVG vendor.c Watertown, MA February 2012  October 2012Director Early Phase Clinical OperationsInitiated/managed first-in-man phase I SAD, MAD, FE study (PRA, the Netherlands) for the PDE10 Program.Managed vendor (CRO) selection; directly managed RFP processes for phase I studies, including renal, hepatic, abuse liability, alcohol interaction, phase II Negative symptoms in Schizophrenia and for a phase III AD Clinical Program.Coordinated protocol development/negotiated study budget for phase I study (CSF amyloid concentrations) in healthy volunteers and in subjects with MCI/AD for the GSM Program.FoldRx Pharmaceuticals, Inc., Cambridge, MA May 2005  November 2011(Acquired by Pfizer, Inc., October 2010)Senior Director Clinical OperationsCoordinated Clinical Operations Team submission of the marketing authorization for tafamidis through the centralized process in the EU; MAA application approved 2011.Conducted audits/training for pivotal trial sites to ensure inspection readiness and adherence to US and international regulations and GCP requirements.Managed due diligence audits resulting in acquisition by Pfizer.Managed and completed 9 phase I, and 4 phase II-III clinical trials (rare disease) in 10 countries (NA, SA, and EU).Directed CRO/vendor selection and management, budget/contract negotiation, investigator and site staff training.Developed clinical protocols/amendments, informed consent forms, case report forms, source documents and clinical study reports.Developed standard operating procedures and established trial master files in accordance with GCP requirements.ActivBiotics, Incorporated, Lexington, MA 2002  2005Director Clinical OperationsReactivated in-licensed IND; planned IND applications for new antibiotic formulations.Directed 5 phase I and 2 phase II trials to support the primary indications.Negotiated contracts with vendors, including CROs, animal research facilities, central labs, EDC concerns, and regulatory/statistical consultants.Prepared, negotiated and managed phase I/II clinical trial budgets.Beth Israel Deaconess Medical Center, Boston, MAAdministrative Director, Office of Clinical Trials and Research (OCTR) 1997  2001Established and directed unique centralized office providing customized clinical trial support services to clinical investigators and industry sponsors. Principal therapeutic areas included cardiology, neurology, Candidate's Name  and hematology/oncology. OCTR facilitated research collaboration with Harvard Medical School, Partners (MGH and BWH) and the Dana Farber Cancer Institute. OCTR services included contracting and budgeting, regulatory submissions, safety reporting, fiscal management, patient recruitment/retention, training and education, and marketing. OCTR successfully managed 250 trials generating $7 million annually.Project Director, Harvard Clinical Research Institute (HCRI) 1995 1997Directed large-scale, multi-center, national/international, phase II/III clinical trials. Responsibilities included the development of investigational plans, case report forms, and manuals of operation. Led project team, established priorities and timelines, and served as the liaison to corporate clients. Conducted nation-wide investigator meetings and monitor training sessions for corporate sponsors.Clinical Research Nurse/Clinical Staff Nurse 19821994Coordinated clinical trials for the Department of Anesthesia and Critical Care, for the Thrombosis and Hemostasis Research Laboratory and for the Department of Candidate's Name s. Clinical staff nurse in the Surgical Intensive Care Unit (SICU) and in the OR.EDUCATIONBachelor of Science in Nursing; BA PsychologyNortheastern University, Boston, MA, 1979CONTINUING EDUCATIONBoston University, Graduate School of Nursing, 1980  1981Simmons College, Graduate Division (Biostatistics and Epidemiology), 1986UMASS Boston, Graduate Division (Business Management), 1999PROFESSIONAL LICENSURECommonwealth of Massachusetts Registration #138471Salzman EW, Weinstein MJ, Weintraub RM, Ware JA, Thurer RL, Robertson L, Donovan A, Gaffney T, Bertele V, Troll J, Smith M, Chute LE. Reduction in Blood Loss after Cardiac Surgery by Vasopressin (DDAVP): A Double-Blind Study. NEJM 1986; 314 (22):1402.Salzman E, McManama G, Shapiro A, Robertson L, Donovan A, Blume H, Sweeney J, Kamm R, Johnson M, Black P. Hemodynamics on Fibrinolytic Activity and Antithrombotic Efficacy with External Pneumatic Cuff Compression. Ann Surg. 1987; 206 (5):636.Gerhart T, Yett H, Robertson L, Lee M, Smith M, Salzman EW. Heparinoid Organon 10172 vs. Warfarin to Prevent Thrombosis After Hip Fracture. Thrombosis & Haemostasis 1989; 62:1534.Gerhart T, Yett H, Robertson L, Lee M, Smith M, Salzman E. Low-Molecular-Weight Heparinoid Compared with Warfarin for Prophylaxis of Deep Vein Thrombosis in Patients Who Are Operated on for Fracture of the Hip. J Bone and Joint Surg. 1991; 73A (4):484.Shorten GD, Seiber T, Maslow AD, Haering JM, Robertson LK, Comunale ME. Left Ventricular regional wall motion and haemodynamic changes following pipecuronium or pancuronium to adult patients undergoing CABG. Canadian J. Anesthesia, 1995; 42 (8):1-6.Comunale ME, Carr JM, Moorman RM, Robertson LK. Significance of D-dimer Concentrations during Cardiopulmonary Bypass. J Cardiothoracic & Vascular Anesthesia. 1996; 10 (4):477-481.Comunale ME, Haering JM, Robertson LK, Lowenstein E. Aspirin prevents protamine induced pulmonary hypertension. IARS. 1997.Baim DS, Cutlip DE, Midei M, Linnemeier TJ, Schreiber T, Cox D, Keirakes D, Popma JJ, Robertson L, Prince R, Lansky AJ, Kalon KK, Kuntz RE. Final results of a randomized trial comparing the MULTI-LINK stent with the Palmaz-Schatz stent for narrowings in native coronary arteries. Am J Cardiol. 2001 Jan 15;87(2):157-62.POSTER PRESENTATIONS: Canney K, Robertson L, Comunale ME. Late Heart Time Study: Improving OR Efficiency for Cardiac Surgery. Health Care Quality Improvement Conference: Generating Multidisciplinary Interchange. Woburn, MA, September, 1993.Haering JM, Comunale ME, Maslow A, Robertson L. On-Line Measurement of Aortic Valve Area Using Multiplane Transesophageal Echocardiography in Patients Undergoing Aortic Vascular Surgery. Poster presentation at the 16th Annual Meeting of the Society of Cardiovascular Anesthesia, Montreal, Quebec, April, 1994.Shorten GB, Comunale ME, Cohen M, Robertson L, Darvish A. Perioperative Arrhythmias in Patients Undergoing Major Vascular Surgery. Poster presentation at the 68th Clinical and Scientific Congress, IARS, March, 1994.Shorten GD, Comunale ME, Maslow A, Haering JM, Robertson L. Myocardial and Hemodynamic Effects of Pipecuronium or Pancuronium 68th Clinical & Scientific Congress, IARS, March, 1994.