Covance Senior Manager Clinical Operations- Line Manager in Muenster, Westfalen, Delaware
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
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 thinkingStrong 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.
Job Number 2018-26037
Job Category Hidden (54285)
Position Type Full-Time
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.