Christopher Bruce Email & Phone Number

Copenhagen, Dk

Bjæverskov, Zealand, Denmark

Bjaeverskov, Denmark

• Optimize the workflow and processes within clinical research • Educate and train employees in how to perform QC and internal audit in clinical trials at research departments• Train and educate staff in how to perform clinical research • Write SOP's and working documents • Review and amend guidelines for clinical research • Develop trial specific templates• Performing submissions to ECs and RAs• Performing validations of sites, initiation visits, monitoring visits, reporting visits, motivational visits, other contacts with sites and close-out visits• Project management of small to large scale projects within production• Implementation of new production processes• Readiness for PPQ and GMP production• Successful completion of production campaigns of products to the market and clinical trials• Close-down of facilities including transfer of equipment and assays

Genntofte, Denmark

Offers consultantcy services within Clinical Research, Trial Management & Project Management

Roskilde, Denmark

• Responsible for the conduct of up to 4 COPD studies; phase I, III and NIS, in parallel• Planning, start-up & conducting global clinical studies including budget planning• Leading cross functional teams of up to 25 people• Training global study teams, local teams and CRO teams in protocols, study specific procedures and documents• Oversight of CRO performance and study delivery• Writing clinical study protocols (phase I, III & NIS), synopsis & develop study specific documents• Developing monitoring strategies (risk-based monitoring & reduced SDV) & study tools• Setting up & maintaining global study budgets and negotiate contracts• Creating recruitment strategies & projections• Conducting & lead internal and external team meetingsAchievements• Writing a phase 3 clinical protocol in 3 weeks weeks which was approved by EMA • Defining & implementing reduced SDV for a large scale phase 3 study, which resulted in better data quality and reduced cost• Representing Clinical Operations in a workgroup, who had to define risk-based monitoring for the company World Wide• Awarded as role model for the company value ‘Passion’ in 2013

Denmark

In-sourced at Bayer and MSD• Feasibilities, pre-study site evaluation visits, initiation visits, monitoring visits, reporting visits, motivational visits and other contacts with sites, performing destruction of study-medication, close-out visits in up to 3 phase II/III studies in parallel. The therapeutic areas were Cardiovascular, Women’s Health and Pulmonary Arterial Hypertension• Clinical Research Manager for teams of up to 8 people• Planning and conducting one-on-one talks with team members, telephone conferences, staff meetings and local investigator meetings• Performing submissions to ECs and RAs• Conducting project management on a National and Nordic level• Conducting co-monitoring visits, reviewing and approving monitoring reports• Training team members and developing study budgets• Developing study aids and tools for national and international use• Conducting international interwise trainingsAchievements• Developing a study drug accountability tool, which was implemented for use at 1300+ sites, and used as a documentation tool at a headquarter audit• Boosting recruitment on a large scale Cardiovascular study with 15% (500 -> 576) over 5 months after a long period with very low recruitment

Denmark

Working for Allergan and Servier• Feasibilities• All kind of monitoring visits in up to 2 phase II - IV studies. The therapeutic areas were Cardiovascular, Urology, Diabetes/Lipids• Destruction of study medication• Giving presentations at investigator meetings

• Performing bone density scans, calculations and analysis of scans• Planning and handling of the patients• Conducting a pilot study on Peripheral Arterial Disease (PAD)

Denmark

• Preparing an investigator initiated study in Circulation• Initiating & assisting sites• Close down of sites and typing in all data results

Bachelor’S Degree, Graduate Diploma In Business Administration - Organization & Managament

Graduate Certificate In Business Administration, Business Administration Part 1, 9.9

Registered Prince2 Practitioner, Prince2

Medicine

Mathematical Student

Education record