Manager/AD Clinical Operations - 100% REMOTE
Posting ID: JP-002664142
This is a remote position for a growing Clinical Development team based in and around the east coast. The assigned clinical trials will be highly complex and high risk, e.g., multiple indications, data monitoring committees, interim analyses, adaptive design, requiring the coordination of multiple vendors, or other special assessments. Candidate may be asked to lead/provide oversight for more than one study or across programs.
- Provide operational expertise and strategic input for assigned clinical trials.
- Provide expertise and operational input into protocol synopsis, final protocol and other study related documents.
- Challenges study team to ensure operational feasibility, inclusive of patient and site burden.
- Validate budget and ensure impacts are adequately addressed.
- Participate in country and site feasibility/selection process, with a focus on providing country insights, corporate agreement, and therapeutic expertise to ensure understanding between study execution plan and program strategy.
- Challenge study team to ensure timelines meet the needs of the clinical development plan.
- Ensure vendors are onboarded.
- Provide guidance to strategic partners/CRO to ensure study issues are addressed and resolved.
- Oversee study budget planning and management, and accountable for external spend related to study execution.
- Oversee strategic partners/CRO/vendor selection, budget and contract negotiation, and proper guidance of performance for all activities assigned to a strategic partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted.
- Approval of essential monitoring documents/plans, periodic review of outputs and actions related to monitoring.
- Review and endorsement of relevant study plans, as applicable.
- Study team meeting management and attendance; regular review of meeting agendas and minutes.
- Review outcomes/actions related to protocol deviations review; primary purpose of review is to help identify trends across sites or the study.
- Documented review and monitoring of risks and decisions at the study level and implementation of mitigation strategies.
- In partnership with data management, review and pressure test all database timelines and plans; ensure linkage between the strategy (i.e., filing/registration, data generation) with the tactical plan for database lock and CSR.
- Ensure studies are "inspection ready" at all times; may be involved in regulatory inspections by preparing for and attending the inspections.
- Help with onboarding and mentoring of new department members
Education & Experience:
· Bachelor's Degree (Life Sciences)
· 4-6 years' experience in pharmaceutical industry or clinical research organization, including 2+ years clinical study management.
· Experience must include Phase 2 and 3 studies (globally recruited).
· Experience in more than one therapeutic area is advantageous. Pediatric experience is a plus.
· Knowledge in global regulatory and compliance requirements for clinical research, including US CFR, EU CTD, and ICH GCP.
· Awareness of local country requirements.
· Excellence in project management and communication.
**For applicants in Colorado**
Compensation is tied to the Colorado market for jobs performed in Colorado. Other locations may be subject to variances based on locations-related factors.
We reserve the right to pay above or below the posted wagebased on factors unrelated to sex, race, or any other protected classification.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. This temporary role may be eligible for the following:
- Medical, dental & vision
- Insurance (Basic/Supplemental Life & AD&D)
- Short and long-term disability
- Health & Dependent Care Spending Accounts (HSA & DCFSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Recruiter: Jean Chambers
Phone: (410) 579-3072