Dr. Carolin Vitten Email & Phone Number

Germany

Dreieich, Hessen, Deutschland

Dreieich, Hessen, Deutschland

Darmstadt, Hessen, Deutschland

• Accountable for the ICF finalization timeline and quality metrics in Phase I-IV studies and identify trends/gaps within the ICF processes, which may impact key deliverables (eg. timelines/quality/costs) and work closely with internal business partners and/or external partners to ensure action or mitigation plans are defined and implemented including CAPA plan at a global or program level • Communicating knowledge and lessons learned within the organization, supporting the development and dissemination of best practices, and proposing process improvements and changes to quality systems.• Supporting clinical teams by applying subject matter expertise to the review and interpretation of Informed Consents (including study, country, and site-level documents) as well as providing support for resolving IRB/IEC queries for global Phase I-IV clinical studies• Provide clinical operations expertise into the cross functional expert group EU CTR Compliance through gap analysis of existing processes and opportunities, applying solutions for outsourced and in-house models.• Acting as the Business Process Owner for Informed Consent including:***Defining/improving processes (SOP writing, ICF manuals and guidance documents) and process goals for Phase I-IV clinical trials at the study, country and site level, ensuring harmonization and standardization across a complex business involving large groups of stakeholders (internal and external).***Establishing quality expectations and operational efficiencies with external alliance partners, identifying trends/gaps, monitoring issues, defining corrective actions, and acting as a point of escalation for issues at the study, project and partnership level.• Evaluating and implementing new technology and software tools for econsent, including vendor management Training of ICF specialists in the role and resonsibilities of developping imhouse Master ICF as well as the study level ICF escalation management

Darmstadt, Hessen, Deutschland

• Provide guidance and expertise on ICF process • Driving the development of Master ICF/s and subsequent amendments, in Phase I-IV studies, with internal and external business partners in a cross -functional matrix environment, in accordance with the requirements of quality, ethical and regulatory standards• Communicating knowledge and lessons learned within the organization, leading the development and dissemination of best practices, and process improvements and changes to quality system• Supporting clinical teams by applying subject matter expertise to the review and interpretation of Informed Consents (including study, country, and site-level documents) as well as providing support for resolving IRB/IEC queries for global Phase I-IV clinical studies.

Darmstadt Und Umgebung, Deutschland

• Development of informed consent process on a CRO Alliance level and within a FSP Model• CRO Oversight and training of CRO partners on global company ICF processe• Active member of the workstream for Informed Consent attribute collection and reporting resulting in the ability to electronically reconcile samples against Informed Consent information in one centralized system- provided training for CROs on process• Development of ICF Core templates such as PGX, future research, pregnant partner• Supporting clinical teams by applying subject matter expertise to the review and interpretation of Informed Consents (including study, country, and site-level documents) as well as providing support for resolving IRB/IEC queries for global Phase I-IV clinical studies

Bad Homburg, Germany

- Built, manage and direct a team of 11 site activation associates and CTAs.- Ensuring successful departmental delivery: goal setting, analyse metrics and key performance indicators, change management and process optimization. • Site activation activities included:• EC/RA submission and site contract negotiation, account set-up, drug release process and site file set-up) both initial and maintenance for Germany, Austria and Switzerland. • Oversee and lead study transitions from CRO to Sponsor and vice versa. • Accountability for 25 studies in start-up phase.

Frankfurt Am Main Und Umgebung, Deutschland

• Oversee and lead study start-up teams to ensure that start-up activities are conducted in an effective manner, meeting timelines and expectations• Site activation activities included: Submission to EC/RA, site contract negotiation and drug release process both initial and maintenance for Germany, Austria and Switzerland• Line managing a team of 17 Associates

Manage all clinical operational aspects in a global phase III study (strategic Alliance Partnership), responsible for 25 countries in Europe. Project oversight in order to meet key deliverables on time during the transition phase from Sponsor to CRO

Manage, coordinate and supervise all activities needed for trial start-up, trial maintenance and trial close out activities ( Phase II to III) according to ICH-GCP including but not limited to site selection, contract negotiation with sites, submission to EC and reg. authorities, vendor and site management, performing PSV, SIV, monitoring and close out visits, site payments, training and mentoring of junior CRAs including line management and report review.Experience in over 13 different indications.

Ph.D, Dr.Rer.Nat., Neuroscience

1. Staatsexamen Für Das Lehramt An Gymnasien, Biology / French