Home-based & Office-based in Istanbul
Clinical Research Manager (CRM) is a Sponsor-dedicated role that serves as the clinical functional lead, accountable for the clinical monitoring / site management delivery of assigned study(ies).
The position as defined by scope provides leadership, mentoring, and technical support to the Clinical Operations team to ensure quality of deliverables and achievement of financial goals.
Role also contains end to end performance and project management for assigned protocols in a country in compliance with ICH / GCP and country regulations, Sponsor policies and procedures, quality standards and adverse event reporting requirements internally and externally.
This role could be responsible for a particular study for several countries in a cluster.
Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).
Responsible for project management of the assigned studies : pro-actively plans, drives and tracks execution and performance of deliverables / timelines / results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
Accountable for performance for assigned protocols in a country in compliance with ICH / GCP and country regulations, Sponsor policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Performs Quality control visits as required
Leads local study teams to high performance : trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration
Ensures compliance with CTMS, eTMF and other key systems in assigned studies
Escalates as needed different challenges and issues to TA Head / CRD / CQM and or CTT (as appropriate)
Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies
Country POC for programmatically outsourced trials for assigned protocols.
Serves local business needs as applicable in his / her country(If delegated can sign contracts and manage budgets)
As a customer-facing role, this position will build business relationships and represent Sponsor with investigators
Proven knowledge in Project Management and site management.
Proven organizational skills with demonstrated success required.
Requires ability to make decisions independently and oversee important activities
relevant to clinical research activities according to predetermined global policies and
commitments with the support, oversight and supervision of the TA Head or CRD
Requires strong understanding of local regulatory environment
Strong understanding of clinical trial planning, management and metrics is essential as
well as the ability to focus on multiple deliverables and protocols simultaneously.
Proficiency in written and spoken English and local language. The incumbent must be
competent and effective in written and verbal communication.
Experience Requirements :
5-6 years of experience in clinical research of which at least 3 as CRA
Bachelor degree in Science (or comparable)
Preferable : Advanced degree, (e.g., Master degree, MD, PhD) preferable
We have a comprehensive benefits package and offer highly competitive remuneration.
Please be advised that due to volume of received applications, only selected candidates will be contacted back.