Job Information
Grifols Shared Services North America, Inc Associate Director, Clinical Operations in RTP, North Carolina
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
Summary:
Oversees the clinical feasibility assessment and strategic planning of clinical trial programs or studies. Executes on these global programs or studies in one or more assigned therapeutic area(s) from DP1 and up to the market authorization. Manages budgets, timelines and quality of deliverables for assigned program(s) and study(ies).
Primary responsibilities for role:
Develops and manages clinical development program plans (e.g., strategies, budgets, timelines).
Provides clinical input/review to clinical documents and ensures the integrity of clinical data prior to submission to regulatory authorities (e.g., protocols, investigator brochures, clinical study reports).
Manages clinical timelines, budgets, and resources against the approved CDP in collaboration with contract manager.
Oversees third party vendors (e.g., contract research organizations (CROs), central labs) and trains them on SOPs, as necessary. Manages the vendor's performance, including on time study completion, budget adherence, and quality deliverables along with the senior management.
Participates in development of vendor specifications to ensure accurate interpretation of the protocol requirements (e.g. processes and data collection)
Drafts clinical components for DP1-DP5 gates and liaise cross-functionally to provide clinical input on all development stages (DP1-DP5) and TPP, as necessary.
Provides oversight and collaboration with Biometry to ensure timely data transfers for data cleaning, review and analysis.
Collaborates with Manager, Clinical Supplies to ensure timely manufacturing, packaging, labeling, shipping of clinical trial supplies for which the incumbent is responsible.
Manages responses to audits, as necessary.
Develops program/study status presentation materials during internal management and advisory meetings.
Maintain awareness of SAEs that are reported
Identifies risks, mitigations, opportunities and contingency plans for assigned program(s) and study(ies).
Manages direct reports through performance evaluations and addressing professional development.
Offers guidance to resolve escalated study conduct issues and provides clinical responses to questions from study center personnel, regulatory authorities and institutional review boards/ethics committees.
Escalates significant issues on program(s) and study(ies) to senior management in a timely manner.
Participant and contributor to internal and external training for clinical program (e.g. Kick-off meeting, Investigator meeting)
Attends cross functional project team meetings.
Maintains good knowledge of the literature for the indication being studied and reviews and summarizes relevant literature for the therapeutic area of interest, as necessary.
Knowledge, Skills, & Abilties:
Good knowledge of good clinical practices (GCPs), code of federal regulations (CFRs), ICH, and clinical trial management including monitoring and study management processes, regulatory requirements, drug safety requirements, data management and statistical processes, budgets, and financial tracking. Good project management skills, including effective planning and organizational skills. Good leadership skills in supervising direct reports and defining strategies for efficient program/study execution. Good verbal, written and interpersonal skills as well as motivational, decision-making and issue resolution skills. Good ability to recognize cultural and regional differences that affect medical standards and patient care. Good ability to manage multiple programs/studies. Good ability to prioritize and effectively manage changing priorities.
Education:
Bachelor’s degree in life sciences or Master’s degree in biomedical science.
Experience:
Typically requires a minimum of 5 years of clinical research experience. (If Master’s degree in biomedical science, equivalency is 2 years of pharmaceutical industry experience in clinical research). Project or technical leadership experience required. Supervisory or management experience preferred.
Equivalency:
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.
Occupational Demands:
Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues.
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
Learn more about Grifols (https://www.grifols.com/en/what-we-do)
Req ID: 512900
Type: Regular Full-Time
Job Category: Clinical Trials