CoHere

Clinical Trial Manager

Therapy area

Experience (yrs)

Location

CT, USA

16 - 20

Oncology, Neuroscience, Infectious Disease, Vaccines

Snapshot

Over 15 years clinical study management experience working in highly matrixed and dynamic environments which include Pharma and Clinical Research Organizations. Strengths include: writing, flexibility, proficient analytic, study management, interpersonal and communication skills, attention to detail, ability to multi-task efficiently, manage ambiguity, lead multi-disciplinary teams, a self-starter and sets priorities to meet aggressive timelines. Therapeutic areas include: CNS, infectious disease, vaccines, oncology (renal cell carcinoma, breast cancer, hepatocellular carcinoma & metastatic colorectal cancer), Cystic Fibrosis and metabolic disease (diabetes). Have managed PI-PIII studies to include study start up, study maintenance and study close out.

Therapy area

Experience (yrs)

Location

NJ, USA

> 25

Broad

Snapshot

Over 25 years of experience working in clinical research with over 15 years of Clinical Project Management experience, which includes 9 years managing Global Oncology projects.

Therapy area

Experience (yrs)

Location

KS, USA

5 - 10

Broad

Snapshot

A highly experienced Senior Clinical Study Manager, Project Management and Leader of TMF with 8 years around the world experience within the CRO, Pharmaceutical environment and Clinical Packaging. Key experiences are within HAL human abuse liability studies, Oncology, Psychiatry/Psychology, Obstetrics/Gynecology and Neurology therapeutic areas. Lead trainer in processes for set up, maintenance, and support for assigned clinical projects. Monitor TMF throughout the study duration, identify and record quality problems, suggest, initiate, recommend or provide solutions as appropriate. Report TMF metrics trending and analysis as appropriate with resolution plans to proactively identify & avoid future issues Prepare/present TMF related information at internal meetings in a globally consistent format. Leader trainer for onboarding new project management. Maintained the TMF for all clinical trials assigned. Act as single point of contact for the client and facilitate responses to Customer questions and observations.

Therapy area

Experience (yrs)

Location

TX, USA

16 - 20

Broad

Snapshot

Infectious Disease (7 years)(Hepatitis C (Genotype 1) Infection 3 Phase III, Chronic Thrombocytopenia with Hepatitis C 3 Phase III, Complicated Serious Skin Infection (CSSI) with Tygacil 1 Phase IV); Oncology (8 years)(Prostate 2 Phase I, Small Cell Renal Carcinoma 2 Phase I, Advanced Solid Tumor 1 Phase I, Non-Small Cell Lung 1 Phase I, Breast 1 Phase I, Breast 1Phase II); Respiratory (4 years)(Inhalant and Subjects With COPD 2 Phase II, Inhalation Solution in Subjects with Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection 2 Phase II, Respiratory Syncytial Infection RSV 4 Phase II); Cardiology (2 years)(Venous Thromboembolism 2 Phase III); Neurology (6 years)(Post-Traumatic Neuropathic Pain 2 Phase III, Multiple Sclerosis 2 Phase IV, Post-Therapeutic Neuralgia 2 Phase III); Musculoskeletal (5 years)(Distal Radius Fracture 2 Phase III, Osteoarthritis 2 Phase III, Knee/Hip Replacement 2 Phase III).

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