- Reporting to the Manager, Clinical Projects, or Director, Medical Affairs [and indirectly to the WW VP, Medical Affairs], the Clinical Project Specialist is accountable for the achievement of key functional business objectives, and oversight of key activities in a platform or program area within Medical Affairs.
- Responsibilities include representing Medical Affairs (MA)/Clinical Operations on Core Teams/Product Development Teams for existing and/or new product initiatives.
- The Clinical Project Specialist demonstrates understanding of advanced technical/scientific principles applicable to the platform/program area of focus and those of associated disciplines (such as R&D, Quality, Business, or Project Management).
- The Clinical Project Specialist represents the interest of the patient and the health care worker and has basic understanding of unmet medical/clinical needs, and provides input into product design on behalf of MA and contributes to ongoing evaluations of product safety.
- The Clinical Project Specialist applies moderate knowledge of clinical trial design and conduct of moderately complex studies when interacting with extended clinical operations team, and may provide input to the clinical development plan.
- The Clinical Project Specialist has working knowledge of local regulations and BD policies and procedures and moderate knowledge of BD products, product development process, ISO standards and elements of design control.
- Responsibilities may also include reviewing and providing input to product labeling and Health Hazard Evaluations.
- The Clinical Project Specialist may contact external KOLs regarding trends in clinical practice and potential impact of product issues.
- The Clinical Project Specialist possesses subject matter expertise in all aspects of clinical trial management, especially project management, good clinical practices (GCP) and human subject protections.
- The Clinical Project Specialist provides MA oversight and expertise to study teams, extended functional teams or work groups, inspires effective business/function dynamics, and imparts a sense of commitment to business/function goals.
Job Summary and Responsibilities:
The Clinical Project Specialist:
- Demonstrates advanced level of technical/scientific discipline applicable to role, and advanced working level understanding of technical aspects of disciplines of key associated disciplines, such as R&D, Quality, Business, Project Management.
- Creates coherent, professional documentation and correspondence of moderate complexity. Is able to draw conclusions from primary and other written and/or verbal sources, present, and / or act on them effectively. Is effective when speaking among peers, team members and functional or Business Management. Work product may require limited review by managers from technical or stylistic point of view.
- Independently develops and prepares training materials consistent with role with technical and stylistic input from more senior associates. Creates and delivers moderately complex presentations to primarily internal audiences; is able to respond to questions extemporaneously.
- Recognizes potential problems and takes preventive steps. Recommends solutions for more complicated or ambiguous issues for consideration. May lead an ad-hoc team to resolve issues.
- Identifies possible process improvement opportunities in own area of responsibility and works to implement them. May participate in CI initiative in own or related area of responsibility.
- Manages multiple complex or multi-stage projects. Is able to mentor/teach others about Project Management principles, tools & processes. Is proficient in the use of formal tools (e.g. MS Project) and creation and/or customization of templates.
- Manages most activities without supervision. Interactions with manager involve periodic updates on activities, discussion of issues, proposals for resolution.
- Asserts own ideas and persuades others. Fosters collaboration among team members. Is recognized as leader within function or business unit.
- Contributes to short term planning and decisions for groups and/or projects.
- Mentors others, including peers in other functions. Suggests development plans and provides feedback.
- Independently estimates resources required. Works with Manager to ensure availability of required supplies and/or resources for individual and/or group activities. Has some impact on quality, cost, and/or productivity. May be asked to provide supporting data for a formal budget process.
- Carries out tasks and activities that are defined by Manager and in local business/operating plans.
- Willingness to travel approximately 10% (domestic and international)
- Bachelor degree required, with preferred education/experience focus in the life sciences, clinical, laboratory or other relevant technical areas.
- Professional certification (clinical research, laboratory) preferred.
- Experience with microbiology platforms is preferred.
- Education and experience sufficient to independently contribute on multi-functional project teams as a subject matter expert in platform area of focus, or on functional teams across businesses/regions.