Clinical Program Manager II
We are currently searching for a skilled professional to join a well-known client’s team as Clinical Program Manager II. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Manage outsourced activities and approved budgets for clinical studies, such as CROs, vendors, bioanalytical labs, and site monitoring to ensure quality deliverables and adherence to study operational plans, timelines, ICH/GCP, protocol requirements, and applicable SOPs
- Coordinate internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical trials
- Assist with protocol design and medical issue resolution
- Contribute to relevant study documentation including clinical protocols, annual safety reports, clinical study reports, etc.
- Create and/or review study operational documents/plans (informed consent form, monitoring plan, data management plan, program management plan, etc.)
- Proactively identify project risks and propose risk mitigations with some supervision
- Participate in the selection of sites, CRO, and vendors
- Participate in study data review and other review activities as assigned
- Work closely with other teams in the organization
- Represent clinical operations in cross-functional initiatives and act on behalf of team, as assigned by management
- Identify program/resource gaps and propose solutions
- Travel to clinical sites for monitoring visits and/or co-monitoring may be required
- May mentor and develop junior clinical operations staff
- Other duties as assigned
- Five or more years of clinical trial management experience specifically in a Sponsor setting
- Three or more years of clinical operations experience as CRA or PM for oncology or pain clinical trial management preferred
- Experience with, and understanding of, ICH and GCP
- Proven track record showing excellent clinical project management skills including clinical supply logistics
- Solid vendor management skills, e.g. CRO, bioanalytical laboratory
- Broad understanding of clinical operations in relation to clinical development functions
- Detailed understanding of all aspects of clinical protocol design and implementation & overall drug development
- Ability to effectively interface with medical personnel at clinical site(s)
- Ability to lead multi-disciplinary teams both internally & externally
- Must have demonstrated problem solving abilities and strong organizational skills.
- Ability to write technical documents, such as protocols, protocol amendments, informed consent, and other trial-related documents
- Detail and team oriented with excellent cross-functional team leadership and participation skills
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- BS or Masters’ Degree in nursing, life science, or related field (or equivalent experience)
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.