Clinical Research Project Manager - Phase I Oncology

Job Overview:

Clinical Research Manager - Phase I Oncology

Home-Based in the USA 

Why settle for one thing when you can have everything?  

Covance gives you the best two-for-one opportunity for career growth.   Who doesn’t want twice the perks?  Working at Covance—one of the largest FSP CROs—and partnering with one sponsor with a dedicated therapeutic focus. You can have it all!

As a Covance employee dedicated to an FSP project, you will bring your specialized discipline to a core team working directly with one sponsor. Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance, Covance has an FSP opportunity to match your area of expertise.

You will enjoy the best of both worlds—all the benefits that come along with Covance’s Energizing Purpose, Exceptional People and Extraordinary Potential combined with working exclusively with one sponsor and this also comes with the benefit of bringing your strong therapeutic experience to allow your expertise to shine through.

Covance’s FSP model is flexible and scalable. Our teams are collaborative and proactive – a great place for you to continue honing your therapeutic skills and growing and excelling in new and exciting research.

Covance’s reach is global – extending to 60+ countries making us one of the largest FSP CROs. No matter where you are located on the globe, we have an FSP opportunity for you.

The Clinical Research Manager is accountable for execution and oversight of local operational clinical trial activities and has ownership, oversight and impact on local regulatory and financial compliance, at a country operations level at the client in compliance with ICH GCP and country regulations.

The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during the study.  As a customer-facing role, this position will build business relationships and represent Client with investigators, functional outsourcing partners and other external partners and therefore have a significant impact on country-level customer relationships. 

In this role, you will be responsible for:

• Effectively conducting clinical studies and developing the pipeline, while maintaining local regulatory and compliance requirements in countries
• Making decisions independently and oversee important activities relevant to clinical research activities in the country according to predetermined global policies and commitments with the support, oversight and supervision of the Country Research Director or Therapeutic Director.
• Building and maintaining professional relationships with investigators and other external stakeholders, with strong communication, educational/pedagogic, diplomatic and empathic skills
• Overseeing country commitments, compliance and training needs. Additionally, business leadership and alignment with corporate requires that individual has ability to lead across several dimensions simultaneously
• Working collaboratively with Country and Regional Operations; Pharmacovigilance, Regulatory, Global Medical Affairs and Global Human Health internally; and with external functional outsourcing vendors
• Coordinating and aligning the regional and broader organization
• Building and maintaining relationships with investigators and other external partners and promote Client’s reputation
• Representing Client in Pharma industry issues and in seeking influence in external R&D environment, in collaboration with CRD
• Accountable for performance and compliance with assigned protocols in relation to ICH/GCP and country regulations along with client policies, procedures and adverse event reporting requirements
• Proactively driving/tracking execution and performance of deliverables/timelines/results to meet country commitments; collaborating with local clinical operations roles; and forecasting country needs
• Overseeing quality and compliance including training. Oversight of CRAs and CTCs including QC visits, Monitoring Visit Reports, escalation of performance issues and training needs; oversees CRMs assigned to client
• Collaborating as the point of contact with outsourcing vendors, investigators, and other external partners; overseeing country and site validations, site selection, and recruitment; and responsible for clients trial education to site.
• Collaborating internally with local PV, Regulatory, GMH/GHH to align key decisions in countries and supporting local/regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional Operations.

Education/Qualifications:

Minimum Required:

• Bachelor’s degree in science or comparable
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
• Thorough understanding of the drug development process
• Fluent in local office language and in English, both written and verbal

Experience:

Minimum Required:

• Minimum of 5-6 years in clinical research in which some experience should be in a CRA capacity.
• 1+ years of experience as a PM or CTL managing oncology projects.
• Must have strong understanding of local regulatory environment, country regulations, client policies and procedures, quality standards.
• Strong scientific and clinical research knowledge is required for this position.
• A strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
• The role will require proven ability to collaborate and lead high performing cross-functional teams also in a virtual environment.
• The position requires strong leadership skills (scientific and business) and ability to coordinate and lead local teams to high performance.
• Good organizational and time management skills
• Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project team and investigative sites preferred
• Excellent communication skills, oral and written
• Self-motivation with the ability to work under pressure to meet deadlines
• Works well independently as well as in team environment
• tail and process oriented
• Positive attitude and approach
• Interact with internal and external customers with high degree of professionalism and discretion
• Multi-tasking capability.
• Good computer skills with good working knowledge of a range of computer packages
• Ability to lead and develop junior staff
• Flexible and adaptable to a developing work environment

Travel Requirements: 

≤ 20-40 % travel may be required. International and Domestic Travel may be required, including overnight stays as necessary consistent with project needs and office location (this will vary based on country and project needs