Clinical Research Manager - FSP

About ExecuPharm

ExecuPharm is the North American clinical operations business within Parexel FSP. We provide biopharmaceutical companies with qualified and talented professionals to accelerate the development and delivery of new therapies.

For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.

Primary Duties:

• Main Point of Contact (POC) for assigned protocols and link between Country Operations (CO) and clinical trial team (CTT)

• Responsible for project management of the assigned studies:

o Proactively plans/drives/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 country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally

o Performs quality control visits as required

o Reviews Monitoring Visits Reports (MVRs) 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:

o Trains in the protocol other local roles

o Closely collaborates with and supports Clinical Research Associates (CRAs) as protocol expert

o 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 Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF) and other key systems in assigned studies

Escalates as needed different challenges and issues to Therapeutic Area (TA) Director / Clinical Research Director (CRD) / Clinical Quality Management (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)

• Shares protocol-specific information and best practices across countries/clusters

• Strong collaboration with local/cluster roles, experience in identifying and sharing best practices across clinical trials, countries, clusters

• Oversees accountability for country/cluster and site validations, site selection and recruitment in assigned protocols

• Country/cluster POC for programmatically outsourced trials for assigned protocols

• Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD, TAH and Regional Operations

• Lead and contribute to initiatives and projects adding value to the business and supporting the strategy

• Responsible for quality and compliance in assigned protocols in country/cluster

• Coordinate study Clinical Trial Coordinator (CTC), Clinical Trial Associates (CRAs), Clinical Operation Manager (COM)

• Contributes to CRM team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required

• Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training

• Adheres to EP and Client SOPs and processesQualificationsSkills and Education:

• Bachelor’s degree in Science (or comparable) required; advanced degree (Master’s degree, MD, PhD) preferred

• 5-6 years of experience in clinical research

• CRA experience preferred

• Knowledge in Project/Site Management

• Strong organizational skills with demonstrated success required

• Requires ability to make decisions independently while overseeing important activities relevant to clinical research in the country according to predetermined global policies and commitments with the support, oversight and supervision of the Therapeutic Area (TA) or Country Research Director (CRD)

• Requires strong understanding of the local regulatory environment

• Strong scientific and clinical research knowledge is required with strong understanding of clinical trial planning, management, and metrics as well as the ability to focus on multiple deliverables and protocols simultaneously

• Experience functioning as a key link between Country Operations and Clinical Trial Teams

• 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; must be competent and effective in written and verbal communication

• Strategic thinking

• Ability to work efficiently in a remote and virtual environment

• Strong leadership skills that enable and drive alignment with the goals, purpose and mission of Client, Global Clinical Development (GCD) and Global Clinical Trial Operations (GCTO)

• Proven strong project management skills and /or project management certification

• Win-win study team approach

• 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 noise. Examples of common problems include low patient recruitment; inadequate staff to meet business needs; performance or compliance issues; working with regulatory issues and the broader organization; and resolution of conflictive situations

• Understands cultural diversity

• Education/pedagogic, diplomatic, and empathetic skills to effectively build and maintain professional relationships with investigators and other external stakeholders

• Travel expectation is up to 30% of working timeEEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.