Tim Schwachula
Clinical Team Manager @Ppd
Signup · Get unlimited contacts
WORK HISTORY
Clinical Team Manager @Ppd
Berlin, DE
Accountable for within-country execution and delivery of assigned studies to timelines, budget and quality expectations as defined in the study protocol as well as in local regulations, IND/ICH GCP guidelines, and sponsor\'s written standards. • Responsible to provide leadership and drive decisions related to the conduct of a clinical study locally including escalating issues when required.• Responsible for matrix leadership and project management of country and site-level activities including oversight of local site management & monitoring activities. • Serves as the operational point-of-contact between the central study team and in-country operational staff, including Clinical Research Associates (CRA) and other in-country staff aligned to the study.
EDUCATION
Humboldt-Universität zu Berlin
Doktor (Ph.D.)
Rheinische Friedrich-Wilhelms-Universität Bonn
Diplom
Distance Learning Institute, Beuth University of Applied Sciences Berlin
Master of Science - MS
SKILLS
ABOUT TIM SCHWACHULA
Doctorate (Dr. rer. nat.) in Molucular Biology (Humboldt University of Berlin), thesis focus on cancer immunology • Master of Science (MSc) in Clinical Trial Management • In-depth knowledge of biomolecular and clinical research and development • >5 years on-the-job experience in clinical research, conducting monitoring visits, site management, clinical project management and regulatory submissions for a variety of protocols, sites and therapeutic areas (oncology, cardiology, gastroenterology, vaccines, and others) in accordance with Good Clinical Practice, local and international regulations • Sustained skills in analytical scientific thinking, structured project management, scientific writing and quality management • Personal capacity in team work and communications
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.