Clinical Project Management Associate

COMPANY:

Discovery Solutions seeks applicants for a Clinical Project Management Associate (5-7 years).

LOCATION:

Indianapolis, IN

SUMMARY:

Clinical Development Manager has responsibility for the technical management and

operational oversight of clinical research trials for assigned assets in the portfolio. The Clinical Development Manager will be responsible for all aspects of global clinical trials

operations, from conception through execution to close out, including timeline creation and management, outsourcing strategy, vendor management, patient recruitment and budget management.

The Clinical Development Manager will achieve this through clinical development

expertise and effective cross-functional partnership with the Asset Team with support

from Senior and Associate Directors, Clinical Operations and Project Management.

The Clinical Development Manager will also provide direction, leadership, and clinical

operations technical/process expertise to their staff.

RESPONSIBILITIES:

Clinical Planning and Execution: Role-based Training Plan (Clinical

Operations I)

Accountable for oversight of clinical operations and delivery of Clinical Project

milestones on time and on budget

o Create and manage implementation timeline and clinical trial activities via the

custom database and Project Management tools

o Accurately forecast and track direct expenses for clinical budgets

Document key team information and clinical decisions in custom

tracking and communication database

o Manage clinical operational risks and their impact to the timelines and

budgets of clinical studies, including critical path activities

Select and manage external network of vendors to ensure on time and on budget

Clinical Project deliverables

o Establish and manage Clinical vendor expectations, performance, and

delivery

Serve as the central point of contact for the global clinical team, to resolve clinical implementation issues (internal and external), lead risk assessments and

contingency planning, and effective communication across and upward

Partner with regulatory and medical to ensure safety management and monitoring processes are implemented

Provide input into molecule development, clinical regulatory and safety strategy

Manage global cross-functional communication and escalations to ensure alignment on delivery and execution

Utilize clinical operations process knowledge to drive decision making.

Participate in review of clinical database specifications and utilization

Manage the writing and approval of informed consent documents

Initiate clinical change control process for studies, as appropriate

Maintain a state of inspection readiness for clinical development inclusive of TMF.

Model essentialism and judgement-based decision making to navigate compliance and quality requirements.

Leadership: Role-based Training Plan

Ensure direct report competencies evolve and address implications to overall

resource management and strategies.

Consistent demonstration of the leadership behaviors

Excellent oral and written communication skills

Proactive communication with asset team members

Strong problem-solving skills

Excellent self-management and organizational skills

Practical experience leading a team of people to deliver on an objective

Able to exercise sound judgment and take and defend tough positions

Ability to use sound judgment when interacting with various sponsors (internal and external) while maintaining the brand image

3. People Management: Role-based Training Plan (Clinical Operations I)

Recruit, develop and retain a diverse and highly capable workforce

Build an organizational culture that fosters diversity, equity, and inclusion

Ensure robust training plan and timely completion of required training for direct

Reports.

QUALIFICATIONS:

Bachelors degree, preferably in a scientific or health-related field

Minimum of 5 years experience in the pharmaceutical industry and/or clinical

development

Early phase clinical trials operations experience preferred, but not required

Must understand clinical development processes and the interdependencies of

various tasks that require coordination among asset team, functional/regional

team members and third parties

Demonstrated core Project Management skills through management of

complex/cross-functional projects, and/or clinical trials with a strong knowledge of regulations and guidelines

Must be capable of managing cross-functional staff in Cork, Ireland

Proven ability to coach and develop others

Ability to embrace the diversity of thought to model innovative behaviors (e.g.,

reaching across boundaries, inspire and empower others and lead decisively in

the midst of ambiguity)

Effective Communication:

Strong communication skills; able to communicate clearly and succinctly with team members and leadership

Ensures effective cross-functional communication with internal and external experts

Additional Skills/Preferences:

Project Management certification (e.g., PMP)

Previous supervisory experience

Strong self-management and organizational skills; able to manage workload, set personal and team priorities and adjust as needed

Able to influence others without direct authority

Strong problem-solving skills: able to anticipate and recognize systemic

problems, diagnose root causes, and take corrective actions to prevent

reoccurrence

Travel may be required