About the Role
Title: Senior Project Manager/ Project Manager: FSP Dedicated Team
Full Time
Location: Remote, Homebased, North America
Discover Impactful Work:
We are seeking a Project Manager/Lead in within our Functional Service Provider Team. This role will be hired at Project Manager OR Senior Project Manager level depending on experience). This role is for the North America region and is remote based.
The PL Is accountable for the overall delivery of the project (quality, time, cost) on behalf of the organization. This individual manages all aspects of assigned clinical trials as well as the study project plan, including timeline, budget, and vendors. Establishes and communicates customer expectations to the project team with minimal direction. Ensures that escalation pathways are adhered to internally and externally. Leads the cross-functional project team to meet or exceed deliverables. Manages project(s) of increasing complexity (such as but not limited to: multi-service, multi-region/country, therapeutic complexity, financial scope).
A day in the Life:
- Serves as the primary contact and lead between the sponsor and the organization at the project level.
- On projects where the scope requires, ensures clear delineation in responsibilities and communication pathways for secondary project leads (such as lead in a specific region, lead for a specific vendor(s) or subset of delivery).
- Drives and owns the overall delivery of the cross-functional project (time, cost, quality).
- Ensures financial stewardship at a project level by demonstrating an intimate understanding of the contract, resource alignment to budget, management of Out of Scope activity, drive the Con Mod process/negotiations and team execution to timelines.
- Establishes, communicates and manages customer expectations to achieve optimal delivery during the project.
- Ensures project team compliance with organization policies, SOPs, ICH- GCP, regulatory and project specific requirements.
Keys to Success:
Education
- Bachelor’s degree or equivalent and relevant formal academic / vocational qualification
Experience
- Previous experience that provides the knowledge, skills, and abilities to perform the job
- Project Manager role: Minimum of 3-5 years experience in clinical research with at least 1-2 years experience in study management preferred
- Senior Project Manager: Minimum of 6+ years experience in clinical research with at least 4 years experience in study management with strong experience with study phases I-IV, global trials, and with complex trial designs. Rare disease study management is recommended
- Proven leadership skills
- Experience in management of: CROs, vendors and consultants
- Documented training, knowledge and application of current FDA/EU Regulations, GCP & ICH guidelines for patient registries and studies
- Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or
- making employment selection decisions.
Knowledge, Skills, Abilities
- Comprehensive therapeutic area knowledge, clinical development guidelines and directives and regulatory guidelines .
- Expert knowledge of the key principles of cross functional project management (Time, Quality, Cost).
- Excellent oral and written communication and presentation skills.
- Demonstrated leadership and interpersonal skills including the ability to lead, motivate and coordinate cross-functional project teams.
- Technical and systems competency, such as computer skills, to include effective use of systems and applications such as Microsoft Outlook, Word, Excel and PowerPoint, as well as organization systems (CTMS, Preclarus, Clarity).
- Proven flexibility and ability to effectively prioritize workload and resources for project team members in a frequently changing environment.
- Skilled in process improvement and strategic development, especially as it applies to clinical trials, clinical development and project management.
- Ability to coach, mentor and lead global and/or cross-functional teams with a cultural awareness.
- Strong financial acumen with an in-depth of knowledge and practical application of budgeting, forecasting and resource management.
- Excellent customer service, consultation and relationship building skills.
- Advanced negotiation and marketing skills with ability to influence others and drive results.
- Excellent judgment, decision making and problem-solving skills and proven ability to apply critical and analytical strategic thinking skills to manage complex/ambiguous situations.
- Proactive, solutions oriented and skilled at risk identification and management.
- Proficient written and verbal communication skills
- Ability to collaborate effectively with the study team, cross functional team members and external partners (including investigator and site staff) using collaborative negotiation skills
- Therapeutic or medical knowledge preferred
- Strong computer skills including knowledge of Excel, Word, PowerPoint and Outlook