Senior Manager Clinical Operations- Line Manager
Covance is looking for a Senior Clinical Operations Manager/ Line Manager to be based in Munich or Bad Homburg
This role is primarily accountable for the end to end performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
- 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, policies and procedures, quality standards and adverse event reporting requirements internally and externally.
- Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
- 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
- Responsible for creating and executing a local risk management plan for assigned studies
- 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
- Serves local business needs as applicable in his/her country (If delegated can sign contracts and manage budgets)
- Collaborates internally with HQ functions and locally with PV, Regulatory and GMA to align on key decisions in his/her studies. GHH to be consulted as needed.
- As a customer-facing role, this position will build business relationships and represent company with investigators
- Shares protocol-specific information and best practices across countries\clusters
Education / Qualifications
- Bachelor degree in Science
- Advanced degree, (e.g., Master degree, MD, PhD
CORE Competency Expectations:
- Previous line management experience of managing managers as well as CRAs
- CRO experience
- Travel required 30-50%
- Managing LMs and CRAs for Covance and Chiltern and will be the local contact especially for Bad Homburg for ClinOps
- Experienced in line and change management
- Strong 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 scientific and clinical research knowledge is required
- Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously
- Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions
- Ability and skills to manage resource allocation, processes (and controls), productivity, quality and project delivery
- Proficiency in written and spoken English and local language. The incumbent must be competent and effective in written and verbal communication.
- Strategic thinking
- Strong leadership skills that enable and drive alignment with the goals, purpose and mission of the company
- Ability to identify problems, conflicts and opportunities early and lead, analyze and prepare mitigation plans and drive conflict resolution is critical.
- Required to negotiate skillfully in tough situations with both internal and external groups; settle differences with minimum disruption.