Interim Lead Clinical Research Associate

Over 20 years of experience in Clinical Research, of which 15 years as Study Manager & Lead CRA on national and international level

Bright field of experience in different indications e.g. oncology and rare diseases

Full responsibility for teams, budgets, timelines, reporting, submissions, protocol monitoring and reviews

Profound knowledge with external service providers such as CROs or CMOs

Site Management including monitoring, close out visits, communication to Ethic Committee and Competent Authorities

Drive enrolment and data quality of the trial

Follow and to maintain scientific and support for the trial

Budget responsibility

Vendor Management

Trial and Site Start-up activities, e.g. recruiting, creating documents, tracker, manuals, protocol, ICF, IB, Risk Management Plan/Communication Plan /TMF Plan, Labels, site documents; budget, contracts (sites, labs, CRO, CMO etc.)

Participate in internal and external communications (e.g., meetings, meeting minutes, etc.); work on regulatory and ethics submissions

Work on electronic and paper document filing (TMF, Site File, Vendor File)

Indication: Oncology, Phase I and II, CAR-T

Vendor management

Planning, implementation and monitoring of all operational processes

Coordinate and adhere to budget framework and timelines, selection and payment processing of required vendors

Reporting internally and externally; oversight on study start-up activities

Indication: Oncology, Phase III, Antibody Drug Conjugate

Budget and contracts preparation and negotiation with trial sites for interventional studies

BfS submissions

Feasibility; Submission to BfArM and Ethics committees of 200 sites in Germany

Communication with Sponsor; regular status calls and emails; contract preparation and review

CRA training and oversight; Site initiation

Indications: Cardiology, Metabolism

Project management of interventional (Phase II and III) and non- interventional studies

Tracing and conduction of feasibility, site initiation, routine on site monitoring including SDV, close out visits

Review of site visit reports

Budget tracking, controlling, contract management, CRO management, coordination of all involved departments (Medical Writing, Medical Experts, Data Management, Statistics), submission to ethics committee and regulatory authorities

eCRF set up

Tracking of invoices and payments to sites; CRA and freelancer management and training, FTE calculation

In this position project management and site monitoring were combined

Indications: Neurology, Metabolism (short stature, orphan drug), Oncology, Endocrinology, Urology